Catheter, Hemodialysis, Non-Implanted

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: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122; HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB/AK-22142-CDC; HEMODIALYSIS KIT 2L: 14 FR X 20CM AGB/AK-25142-CDC; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UMD; HEMODIALYSIS KIT: 2L 14 FR X 15 CM/ASK-22142-UNC; HEMODIALYSIS KIT: 2L 14 FR X 20 CM/ASK-25142-UMD; HEMODIALYSIS KIT 2L: 14 FR X 20 CM AGB/ASK-25142-UN1; HEMODIALYSIS KIT: 2L 14 FR X 25 CM/ASK-26142-UMD; HEMODIALYSIS KIT: 2LUMEN 12 FR X 13 CM/AU-23122-F; HEMODIALYSIS KIT: 2LUMEN 12 FR X 20 CM/AU-25122-F; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-X1A; HEMODIALYSIS KIT: 2L 12 FR X 16 CM AGB/CDC-22122-XU1A; HEMODIALYSIS KIT: 2L 14 FR X 15 CM AGB/CDC-22142-X1A; HEMODIALYSIS KIT: 2L 12 FR X 25 CM AGB/CDC-26122-X1A; HEMODIALYSIS KIT 2L: 12 FR X 16CM AGB/AK-22122-CDC; HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-22122-F; HEMODIALYSIS KIT: 2-LUMEN 14 FR X 15 CM/AK-22142-F; AHDC AGB U-BEND KIT: 2-L 12 FR X 16 CM/CDC-22122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 15 CM/CDC-22142-CN1AC; AHDC AGB U-BEND KIT: 2-L 12 FR X 13 CM/CDC-23122-CN1AU; AHDC AGB U-BEND KIT: 2-L 12 FR X 20 CM/CDC-25122-CN1AU; AHDC AGB CURVED KIT: 2-L 14 FR X 20 CM/CDC-25142-CN1AC;

  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.

• 2026-06-05Open, ClassifiedUnder Investigation by firm

  Mahurkar Elite PASS Trays; Description (Product Number/CFN): 12 FR x 13cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221413), 12 FR x 16cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222416), 12 FR x 16cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221416), 12 FR x 20cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222420), 12 FR x 20cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221420), 12 FR x 24cm Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888222424), 12 FR x 24cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221424), 12 FR x 30cm Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888221430), 12.5 FR x 13 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233413), 12.5 FR x 16 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233416), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233420), 12.5 FR x 20 cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231420), 12.5 FR x 24 cm Acute Triple Lumen Catheter with Curved Extensions, PASS Tray (8888233424), 12.5 FR x 24 cm, Acute Triple Lumen Catheter with Straight Extensions PASS Tray (8888231424), 12.5 FR x 30 cm, Triple Lumen Catheter with Straight Extensions PASS Tray (8888231430), 12.5FR x 13cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231413), 12.5FR x 16cm Acute Triple Lumen Catheter with Straight Extensions, PASS Tray (8888231416), 13.5 FR x 16 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213416), 13.5 Fr x 16cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211416), 13.5 FR x 20 cm High Flow Acute Dual Lumen Catheter with Curved Cannula, PASS Tray (8888213420), 13.5 Fr x 20cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211420), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212413), 13.5FR x 13cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211413), 13.5FR x 16cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212416), 13.5FR x 20cm High Flow Acute Dual Lumen Catheter with Curved Extensions, PASS Tray (8888212420), 13.5FR x 24cm High Flow Acute Dual Lumen Catheter with Straight Extensions, PASS Tray (8888211424); for acute hemodialysis, aphaeresis, and infusion.

  The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays.

• 2018-02-20TerminatedProcess control

  ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018

  These finished good kits may contain the incorrect Springwire Guide (SWG).

• 2015-08-18TerminatedLabeling Change Control

  RenLane Renal Denervation Catheter; Cat No.: D135601. Used in adults patients (>18 years) with drug resistant hypertension to denervate the renal arteries to reduce blood pressure.

  Potential Damage may occur to the helical tip of the RENLANE Renal Denervation Catheter, if the hemostasis valve of the arterial access device is not fully open before insertion or withdrawal of the catheter.

• 2007-09-20TerminatedOther

  Guidewire, 70cm x 1mm, REF 5583705, Sterile, Single Use, BARD Access Systems, Hemodialysis Catheter, Salt Lake City, UT 84116.

  Metal guidewires used in Hemodialysis Catheters may have been reverse loaded within the dispenser. Potential exists for the stiff end of the guidewire to be inserted into the patient instead of the flexible end.

• 2004-07-20TerminatedOther

  Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions

  catheter slips out of the suture wing during use.

• 2003-12-17TerminatedOther

  Mahurkar QPlus Dual Lumen Catheter Kit with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion. Reference: 8888-135192

  Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5Fr x 16.0 cm

• 2003-12-17TerminatedOther

  Mahurkar QPlus Dual Lumen Catheter Insertion Tray with Curved Extension, 13.5 Fr/Ch x 19.5cm For hemodialysis, apheresis, and infusion Reference: 8888-135195

  Product is mislabeled to catheter length. Product labeled as a 13.5 Fr x 19.5 cm may contain a 13.5 Fr x 16.0 cm

• TerminatedProcess control

  MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays. Product Number: 8888222316.

  Medtronic is voluntarily recalling one lot of its MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays, Lot 1717900160, following notification from our supplier that one production lot of MAHURKAR"* Elite 12 FR x 16cm Acute Dual Lumen Dialysis Catheter with Curved Extensions, IC Trays was inadvertently shipped to Medtronic and distributed without being sterilized.

• TerminatedProcess control

  ARROWg+ard Blue Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions (1) Part Number (PN): CDC-22122-1A; (2) PN: CDC-25122-1A; (3) PN: CDC-25142-1A; (4) CDC-26142-1A

  Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.