Needle, Catheter
FDA adverse event reports and recall history for needle, catheter (product code GCB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 393
- Deaths
- 5
- Injuries
- 135
- Malfunctions
- 242
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
- 2024-04-12Open, ClassifiedUnder Investigation by firm
Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous fluid aspirations, such as paracentesis or thoracentesis. REFERENCE PART NUMBER (RPN): DTVN-5.0-19-10.0- YUEH ORDER NUMBER (GPN): G09490
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
- 2015-07-17TerminatedMixed-up of materials/components
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior sealed STERILE KIT is correct and NO adverse issues affect that part of the item. The NON-STERILE OUTSIDE "PIGGYBACKED" PACKAGE mistakenly contains ITEM #8881579121 - Syringe prefilled, Saline Flush, 09% Sodium Chloride and is a NONSTERILE PRODUCT that CANNOT BE DROPPED INTO THE STERILE FIELD.
- 2014-12-12TerminatedProcess control
Rapid Centesis Catheter, 5 Fr x 7 cm Catheter, Ref No. M7513 Product Usage: Short term percutaneous fluid drainage
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
- 2014-12-12TerminatedProcess control
Thoracentesis & Paracentesis Procedure Tray, Ref No. M7553, 850004 Product Usage: Short term percutaneous fluid drainage.
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
- 2014-12-12TerminatedProcess control
Veta Peritoneal Catheter Kit, Curled, Ref No. M7225 Product Usage: Veta Peritoneal Dialysis Catheters are intended for acute and chronic access to the peritoneal cavity.
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
- 2013-09-11TerminatedProcess change control
*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA. Indicated for specimen retrieval and therapeutic drainage of the pleural cavity.
Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, preventing drainage of excessive fluid from the pleural cavity leading to a potential delay in the medical procedure and potentially serious patient complications.
- TerminatedMixed-up of materials/components
CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986
The 8 Fr catheter was manufactured with the 6.9 Fr needle instead of the 8 Fr needle.
- TerminatedUnder Investigation by firm
Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue dilation with subsequent positioning of a guidewire for catheter placement in non-vascular procedures.
Tungsten coils of the guidewire included in the introducer kit were detaching.
Monitor needle, catheter automatically
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