Electrode, Pacemaker, Temporary

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-06-13Open, ClassifiedNonconforming Material/Component

  Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGU

  Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

• 2024-09-06Open, ClassifiedUnder Investigation by firm

  Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

• 2024-09-06Open, ClassifiedUnder Investigation by firm

  Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J ; 2) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AG; 3) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398650AI; 4) ANGIOGRAPHY DRAPE PK, Pack Number 00-398712S ; 5) CATH LAB PACK , Pack Number 00-398725AM; 6) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399360K ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399734N ; 8) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983Q ; 9) ANGIOGRAPHY DRAPE PACK, Pack Number 00-399983R ; 10) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400065K ; 11) ANGIO PROCEDURE PACK, Pack Number 00-400069F ; 12) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AC; 13) ANGIOGRAPHY DRAPE PACK PTCA , Pack Number 00-400123AD; 14) ANGIO PROCEDURE PACK, Pack Number 00-400290D ; 15) ANGIOGRAPHY DRAPE PACK, Pack Number 00-400305Q ; 16) MOUNT SINAI HOSPITAL-ANGIO PK , Pack Number 00-400763F ; 17) ANGIOGRAPHY DRAPE PACK-LF , Pack Number 00-400863J ; 18) ANGIOGRAPHY DRAPE , Pack Number 00-400932O ; 19) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401030S ; 20) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401178D ; 21) ANGIO PROCEDURE PACK, Pack Number 00-401189I ; 22) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401226K ; 23) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318L ; 24) ANGIOGRAPHY DRP PK PEDI CATH, Pack Number 00-401318M ; 25) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401327Y ; 26) CORONARY ANGIO PACK-LF, Pack Number 00-401594Q ; 27) ANGIOGRAPHY DRAPE PACK, Pack Number 00-401620J ; 28) ANGIO PROCEDURE PACK, Pack Number 00-401824AA; 29) CATH LAB PACK-LF, Pack Number 00-HCT055P ; 30) CATH ACCESSORY PACK , Pack Number 0M-CP31433G; 31) CATH ACCESSORY PACK , Pack Number 0M-CP31433I; 32) ANGIO PACK, Pack Number 0M-CP31933C; 33) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357I; 34) ANGIOGRAPHY PACK-LF , Pack Number 0M-CP32357J; 35) ANTERIOR CERVICAL CDS-LF, Pack Number CDS982292D ; 36) CABG 1, Pack Number CDS983663J ; 37) CATH CDS, Pack Number CDS984141I ; 38) ENDO AAA, Pack Number CDS984264I ; 39) ANGIOGRAPHY OR, Pack Number CDS984944C ; 40) ACCESS CATHETER , Pack Number CDS985507F ; 41) ARTHROSCOPY SHOULDER, Pack Number CDS985509F ; 42) SYMPHONY 5FR CATHETER KIT , Pack Number CTK-5K ; 43) SYMPHONY MAX 6FR CATHETER KIT , Pack Number CTK-6K ; 44) NEURO ANGIO PACK, Pack Number DYNDA1431A; 45) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0048560A ; 46) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429L ; 47) SJ CATH LAB PACK-LF , Pack Number DYNJ0101429N ; 48) ANGIO TRAY-LF , Pack Number DYNJ0131200P ; 49) ANGIOGRAM , Pack Number DYNJ0149444J ; 50) ANGIOGRAM , Pack Number DYNJ0149444K ; 51) ANGIOGRAM , Pack Number DYNJ0149444M ; 52) EP LAB DEVICE PACK-LF , Pack Number DYNJ0160556D ; 53) PED CATH PROCEDURE CHILD PK-LF, Pack Number DYNJ0161241F ; 54) ANGIO PACK-LF , Pack Number DYNJ0165039M ; 55) ANGIO PACK-LF , Pack Number DYNJ0165039N ; 56) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AF; 57) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0194989AG; 58) VASCULAR ANGIO PACK-LF, Pack Number DYNJ0201109AG; 59) ANGIOGRAPHY TRAY-LF , Pack Number DYNJ0220880V ; 60) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0241256L ; 61) ANGIO PACK-LF , Pack Number DYNJ0281048I ; 62) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0290716L ; 63) ANGIO PROCEDURE PACK-LF , Pack Number DYNJ0298504AG; 64) ANGIOGRAPHIC PACK-LF, Pack Number DYNJ0337491C ; 65) ARTERIOGRAM PACK-LF , Pack Number DYNJ0362293D ; 66) CATH LAB PACK-LF, Pack Number DYNJ0362352M ; 67) CATH PACK-LF, Pack Number DYNJ0367643Q ; 68) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0370415I ; 69) CATH LAB PACK-LF, Pack Number DYNJ0371696O ; 70) ANGIOGRAPHY PACK-LF , Pack Number DYNJ0372025G ; 71) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098K ; 72) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098L ; 73) OR ANGIOGRAPHY PACK-LF, Pack Number DYNJ0373098M ; 74) ANGIOGRAPHY DRAPE PACK-LF , Pack Number DYNJ0373221O ; 75) ANGIO PACK-LF , Pack Number DYNJ0373279M ; 76) INTERVENTIO

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

• 2024-09-06Open, ClassifiedUnder Investigation by firm

  Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036OH; 3) CATH ACCESSORY PACK, Pack Number 0M-CP31433J; 4) 3" RADIAL ARTERIAL LINE KIT- OR, Pack Number ART1210; 5) PERF. ASSOC. CUT DOWN TRAY, Pack Number BM17BAD; 6) CATHETER ADD A CATH TRAY, Pack Number CVI4970; 7) BIOPSY TRAY, Pack Number DYNDH1129; 8) ARTHROGRAM TRAY, Pack Number DYNDH1134; 9) BRISTOL MYELOGRAM, Pack Number DYNDH1228; 10) LUMBAR TRAY, Pack Number DYNDH1540A; 11) RADIOLOGY BASIC PACK, Pack Number DYNDH1827; 12) BLOOD CULTURE KIT W/BOTTLES, Pack Number DYNDH1932; 13) BIOPSY PACK, Pack Number DYNDL1462B; 14) CATH LAB PACK-LF, Pack Number DYNJ0105963Q; 15) CARDIAC CATH HARPER PACK-LF, Pack Number DYNJ0161912G; 16) CATH LAB PACK-LF, Pack Number DYNJ0173400P; 17) CATH LAB PACK-LF, Pack Number DYNJ0194968AG; 18) PICC LINE PACK-LF, Pack Number DYNJ0275614F; 19) PEDI CATH PACK-LF, Pack Number DYNJ0429201L; 20) SPECIAL PROCEDURE ANGIO PACK, Pack Number DYNJ04386U; 21) RADIOLOGY PACK, Pack Number DYNJ04562S; 22) IR PACK, Pack Number DYNJ04674U; 23) IR PACK, Pack Number DYNJ04674UH; 24) LEFT HEART PACK-LF, Pack Number DYNJ0490280PH; 25) LT HEART/ANGIOGRAPHY PACK-LF, Pack Number DYNJ0537652AG; 26) SM CARDIAC CATH PACK-LF , Pack Number DYNJ0621195TH; 27) CATH LAB PACK-LF, Pack Number DYNJ0755738R; 28) CARDIAC CATH PACK-LF, Pack Number DYNJ0781476AAH ; 29) CARDIAC CATH PACK-LF, Pack Number DYNJ0781918NH; 30) CATH LAB PACK , Pack Number DYNJ07919GH; 31) PACEMAKER PACK-LF , Pack Number DYNJ0830939ACH ; 32) CARDIAC CATH PACK-LF, Pack Number DYNJ0843627G ; 33) PICC INSERTION PACK-LF, Pack Number DYNJ0880659D; 34) PEDS HEART CATH PACK-LF, Pack Number DYNJ0897998D; 35) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414BH; 36) RADIAL ARTERY CATH PACK-LF, Pack Number DYNJ0945414CH; 37) CATH LAB PACK , Pack Number DYNJ10117JH; 38) CARDIAC CATH PACK, Pack Number DYNJ17081S; 39) DEPAUL ANGIO PROCEDURE PACK, Pack Number DYNJ19937I; 40) PV/PTA TRAY-RF, Pack Number DYNJ21944VH; 41) ANGIO TRAY, Pack Number DYNJ23438M; 42) ANGIO TRAY, Pack Number DYNJ23438N; 43) ANGIO TRAY, Pack Number DYNJ23438O; 44) ADULT CARDIAC CATH PACK, Pack Number DYNJ23455Q; 45) VIR PACK, Pack Number DYNJ23499MH; 46) HEART CATH-SMH, Pack Number DYNJ24483FH; 47) CATH LAB PACK , Pack Number DYNJ24802PH; 48) ANGIO DRAPE PACK, Pack Number DYNJ24806KH; 49) RADIOLOGY STD TRAY, Pack Number DYNJ25029RH; 50) CARDIAC CATH PACK, Pack Number DYNJ26305N; 51) DIAGNOSTIC ADULT-LF , Pack Number DYNJ27239DH; 52) HEART CATH LT PACK, Pack Number DYNJ31282I; 53) ANGIO PACK, Pack Number DYNJ31339I; 54) CARDIAC CATH PACK, Pack Number DYNJ31847I; 55) NEURO ANGIO TRAY-LF, Pack Number DYNJ34882M; 56) HEART CATH II PACK CHS-LF, Pack Number DYNJ35605M; 57) ISSAQUA CATH/IR PACK, Pack Number DYNJ36738G; 58) PEDS CARDIAC PACK, Pack Number DYNJ37418MH; 59) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050F; 60) SPECIAL PROCEDURE PACK-LF, Pack Number DYNJ38050FH; 61) SPECIAL PROCEDURE PACK, Pack Number DYNJ38314G; 62) MINOR SPECIAL PROCEDURE PACK, Pack Number DYNJ38326G; 63) CARDIAC CATH PACK, Pack Number DYNJ38866F; 64) PERM CATH TRAY, Pack Number DYNJ40423AH; 65) O R EMERGENCY PACK, Pack Number DYNJ40460CH; 66) CARDIAC CATH PACK, Pack Number DYNJ40511M; 67) CATH LAB PACK, Pack Number DYNJ40961A; 68) CARDIAC CATH TRAY, Pack Number DYNJ41050C; 69) CATH LAB PACK, Pack Number DYNJ43469D; 70) PK, RADIOLOGY, Pack Number DYNJ43816B; 71) CARDIAC CATH TRAY, Pack Number DYNJ45323F; 72) LEFT HEART, Pack Number DYNJ45984I; 73) CATH LAB PROCEDURE, Pack Number DYNJ46353F; 74) ANGIO PACK, Pack Number DYNJ46401B; 75) CARDIAC CATH TRAY, Pack Number DYNJ46402A; 76) CARDIAC CATH TRAY, Pack Number DYNJ46419C; 77) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646D; 78) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646F; 79) NEURO CATH PACK (NCLUA)227-LF, Pack Number DYNJ47646G; 80) NEURO

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

• 2018-11-08TerminatedDevice Design

  TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

  During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.

• 2013-05-30TerminatedProcess design

  Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.

  On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.

• 2013-05-30TerminatedProcess design

  Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.

  On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.

• 2012-10-29TerminatedProcess control

  Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.

  Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification.

• 2012-02-15TerminatedProcess design

  Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce (MEDICAL CONCEPTS EUROPE) --- Manufacturer ECM B.V. Oost-Om 54, P.O. Box 53, NL 5420 AB GEMERT --- Shipping or Unit Package: 20 individual units packaged per box with 6 boxes per case. --- Device Classification Name: Electrode, pacemaker, temporary. ---The device is supplied sterile and intended for single use. Used to pace the heart during or after open heart surgery. The electrodes are placed on the heart; the other end of the pacing wire is inserted through the skin of the patient with a thoracic needle. The thoracic needle can snap-off at the end where the pacing wire is attached, after snap-off the remaining pins are connected to an external pacemaker. For temporary atrial and ventrical pacing and sensing for contemplated implant duration of 7 days or less.

  The crimping operation during product production was not performed properly. As such, the pacing wire may separate from the connection pin, which causes non-functionality.

• 2009-06-24TerminatedDevice Design

  Arrow Balloon and stylet temporary pacing catheter

  Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.