Accessories, Catheter

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

• 2025-11-26Open, ClassifiedProcess control

  IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. PB1500 15 DROP IV SET W/2 STOPCOCKS; Catalog Number: 490025.

  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

• 2025-11-26Open, ClassifiedProcess control

  IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1503 15 DR UNIV SPIKE, INJ SITE, BCV; Catalog Number: 490062.

  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

• 2025-11-26Open, ClassifiedProcess control

  IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/10 DROPS, 138 IN.; Catalog Number: 490426.

  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

• 2025-05-07Open, ClassifiedProcess control

  GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.

  Due to a potential open seal in the sterile barrier packaging .

• 2020-12-14TerminatedProcess control

  Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

  Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.

• 2016-08-22TerminatedUnknown/Undetermined by firm

  Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

  Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

• 2016-08-22TerminatedUnknown/Undetermined by firm

  Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures

  Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

• 2010-10-28TerminatedLabeling mix-ups

  IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.

  Graft Jacket Xpress kits contain catheters that will expire or have already expired prior to the labeled expiration of the human tissue component of the product on the outer box.

• 2010-08-25TerminatedProcess change control

  Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801

  Sterility not assured. The stopcock handle position was inadvertently changed from an open to a closed position, which prevents sterilization of the closed portion of the device. Sterility of the affected product cannot be guaranteed.

• 2010-05-05TerminatedPackaging

  Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605 Permits venous access and catheter introduction to the central circulation.

  Some central venous catheter sets had the incorrect lid stock.