Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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, ClassifiedNonconforming Material/Component

  CK000662 PowerPICC SOLO HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741129674 Catheter stylets provide internal reinforcement to aid in catheter placement.

  Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

• 2026-07-02Open, ClassifiedNonconforming Material/Component

  1274108D PowerPICC SV Catheter 4 Fr Dual-Lumen REKW2449 00801741087110 3173108D PowerPICC SV Catheter 3 Fr Single-Lumen REKV2227 00801741027536 The PowerPlCC SV catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

  Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

• 2026-07-02Open, ClassifiedNonconforming Material/Component

  CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741223020 CK001066 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228544 CK001068 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228728 S1173108D PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130342 S1173108D1 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154720 S1173108D4 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155031 S1173108D5 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155130 S1173108D6 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741232190 S1193108D3 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154980 S1193108D4 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155086 S1193108D5 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155185 S1193108PD PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741134135 S1274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130366 S1274108D4 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155055 S1274108D5 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155154 S1294108D PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130373 S1294108D2 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154898 S1294108D4 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155109 S1294108D5 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155208 S3173108 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130144 S3274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130403 S9274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130441 The PowerPICC Provena Catheters and PowerPICC Provena Catheter with SOLO Valve Technology are indicated for short and long term peripheral access to central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allow for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 guage or larger be used.

  Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

• 2026-07-02Open, ClassifiedNonconforming Material/Component

  7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

  Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

• 2026-07-02Open, ClassifiedNonconforming Material/Component

  1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034602 1174108D3 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1174108D4 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155048 1174108D5 PowerPICC Catheter 4 Fr Singel-Lumen UDI-DI Code: 00801741155147 1194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741034510 1194108D1 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154782 1194108D4 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155093 1194108D5 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741155192 1275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034558 1295108FD PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741034626 3194108D PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741027727 3275108D PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741027871 3295108D PowerPICC SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741028052 9194108D PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035609 CK000267A PowerPICC SOLO2 Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741185021 CK000289C PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741161148 CK000293 PowerPICC HF Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741038020 CK000586B PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741212789 CK000613 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121395 CK000631B PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741143748 CK000632B PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741143755 CK000746A PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741227066 CK000886 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741188831 CK000966A PowerPICC Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741215858 CK000988 PowerPICCProvena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741216022 CK001006 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741219849 CK001030 PowerPICC SOLO Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741223976 S1275108FD2 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-Di Code: 00801741154850 S1275108FD3 PowerPICC Provena FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741154959 S1295108FD1 PowerPICC Provena Catheter SOLO 5 Fr Dual-Lumen UDI-DI Code: 00801741154805 S1295108FD3 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155017 S1295108FD5 PowerPICC Provena SOLO FT Catheter 5 Fr Dual-Lumen UDI-DI Code: 00801741155215 S1385108D PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112720 S1385108D2 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154867 S1385108D3 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154966 S1385108D4 PowerPICC Provena Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155079 S1395108D PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741112751 S1395108D1 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154812 S1395108D2 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741154911 S1395108D3 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155024 S1395108D4 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155123 S1395108D5 PowerPICC Provena SOLO Catheter 5 Fr Triple-Lumen UDI-DI Code: 00801741155222

  Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

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

  Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45 CM/ASK-44552-ABKB; AGBA PICC/DELTA KIT: 5.5 FR X 55 CM/ASK-45552-MHBV; AGBA PICC: 1L 4.5FR x 55CM w Biopatch/DLX-45541-HPKB; PICC/DELTA KIT: 2L 5.5 FR X 50 CM/ASK-45052-MC; AGBA PI PICC KIT: 1L 4.5FR 40CM/CDC-44041-HPK1A; AGBA PI PICC KIT 2-LUMEN: 5.5 FR X 40CM/CDC-44052-HPK1A; AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM/CDC-44052-VPS2; PI AGBA PICC KIT: 3-L 6 FR X 50 CM/CDC-45063-HPK1A; AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM/CDC-45541-VPS2; AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM/CDC-45552-VPS2; PICC/VPS 1L 4.5 FR/ASK-45541-CHS; PI AGBA PICC KIT: 1L 4.5 FR X 55 CM VPS/ASK-45541-UOI2; PICC KIT: 2L 5.5FR 55CM AGBA VPS/ASK-45552-CHS; PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS/ASK-45552-UOI2; PICC KIT: 3L 6FR 55CM AGBA/ASK-45563-CHS; PI JACC KIT: 3L 6 FR X 25 CM CG+/ASK-42563-LTAC; PI JACC KIT: 1-L 4.5 FR X 25 CM CG+/CDC-42541-JX1A; PI JACC KIT: 2-L 5.5 FR X 25 CM CG+/CDC-42552-JX1A; PI JACC KIT: 3-L 6 FR X 25 CM CG+/CDC-42563-JX1A; PI JACC KIT: 2-L 5.5 FR X 30 CM CG+/CDC-43052-JX1A; PI JACC KIT: 3-LUMEN: 6 FR X 30 CM CG+/CDC-43063-JX1A; PICC KIT: 2-L 4 FR X 55 CM/CDC-05542-PK1A

  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.

• 2026-02-13Open, ClassifiedProcess control

  Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060

  Due to damage to outer tray that can potentially compromise the sterile barrier

• 2025-04-16Open, ClassifiedProcess control

  BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK000483, 3174335, 3174355, CK000196, 9174118, CK000955, 3174135, CK000617, CK000839, 3194355, 6174118, 3194135, 3194335, 2174108, 9194118, 3194118, 1174118, CK000285C, CK000335A, CK000796, 1194108D, CK000757, CK001042, 9174108, 1174108D1, CK000631B, 3194155, 3174108, CK000567, 1194108D4, 1174108D2, CK000677, CK000864, CK000937A, CK000930, CK001027, 1174108D, CK000867, CK000900, CK000315A, CK000589A, CK000854B, CK000897, CK000953A, CK000586B, CK000549, CK000844, 1194108D1, 1174108D4, 1194108D3, CK000934, CK000986, CK000411, CK001018, 1174108, CK000060, CK000513A, CK001021, CK001030, CK000501A, CK000619A, CK000903, 3194108, 1194108D2, 9194108D, CK000959, CK000613, CK000991, CK000983, CK000881, CK000721, CK000642, CK000289C, CK000894A, CK000914, CK000445, CK000687, CK000524A, CK000819, CK000266A, 1174108D3, 3194108D, CK000545, 1174108D5, 3174108D, CK000775A, 1194108D5, CK000736, CK000739, 9194108, 1194108, CK000660, CK000609A, 9174108D, CK001067, CK000077D, CK000882, CK000874, CK000994, CK000870A, CK000443C, CK000668B, CK000784

  Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

• 2024-08-16Open, ClassifiedEmployee error

  L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539

  Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.

• 2023-10-13Open, ClassifiedError in labeling

  HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002

  Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.