Catheter, Recording, Electrode, Reprocessed
FDA adverse event reports and recall history for catheter, recording, electrode, reprocessed (product code NLH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 445
- Deaths
- 1
- Injuries
- 66
- Malfunctions
- 377
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
- 2026-07-02Open, ClassifiedUnder Investigation by firm
Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 4 Elec. 10mm; Item no. 401305RH, St. Jude Medical Response" Diagnostic Electrophysiology Catheter 10 Elec. 2-5-2mm.
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
- 2026-05-13Open, ClassifiedProcess control
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- 2026-05-13Open, ClassifiedProcess control
BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- 2026-05-13Open, ClassifiedProcess control
BARD Dynamic Tip Steerable, Product Number 200344; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- 2026-05-13Open, ClassifiedProcess control
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Incomplete seals on sterile product
- 2026-05-13Open, ClassifiedProcess control
BARD Dynamic XT Deca Steerable, Product Number 201102, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- 2026-05-13Open, ClassifiedProcess control
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- 2026-05-13Open, ClassifiedProcess control
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- 2026-05-13Open, ClassifiedProcess control
BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
- 2026-05-13Open, ClassifiedProcess control
BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Incomplete seals on sterile product
Monitor catheter, recording, electrode, reprocessed automatically
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