Catheter, Peritoneal, Long-Term Indwelling
FDA adverse event reports and recall history for catheter, peritoneal, long-term indwelling (product code FJS), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 2,347
- Deaths
- 46
- Injuries
- 965
- Malfunctions
- 1,217
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
- 2023-04-07Open, ClassifiedSoftware Manufacturing/Software Deployment
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Product that was built for design verification testing was inadvertently distributed to customers.
- 2014-12-12TerminatedProcess control
ASEPT 2000 ml Drainage Bag, Ref No. 622280 Product Usage: The ASEPT Drainage Bag is to be used for peritoneal drainage with the ASEPT Peritoneal Drainage Catheter only.
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
- 2011-08-08TerminatedError in labeling
Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
Labeling for drainage kit contained incomplete information.
- 2011-08-08TerminatedError in labeling
Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
Labeling for drainage kit contained incomplete information.
- 2011-08-08TerminatedError in labeling
Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
Labeling for drainage kit contained incomplete information.
- 2011-08-08TerminatedError in labeling
Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal Drainage system is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the peritoneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
Labeling for drainage kit contained incomplete information.
- TerminatedMixed-up of materials/components
Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled, Catalog # CF-4235/B
2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product.
- TerminatedPackaging process control
Flex-Neck Classic Peritoneal Dialysis Catheter (Pediatric) Product Usage: If the patient is a suitable candidate for peritoneal dialysis (PD) therapy, The Flex-Neck PD Catheter can be implanted either surgically or peritoneoscopically. The only contraindication to implantation of the FlexNeck PD Catheter is if the patient is not a candidate for peritoneal dialysis. Numerous prior surgeries or suspected or documented intraperitoneal adhesions may be relative contraindications to PD. However, since the Y-TEC System of peritoneoscopic implantation enable inspection of the peritoneum to confirm the presence of adhesions and to avoid them, all patients who are suitable for PD can receive this catheter.
Mix-up between adult and pediatrics PD catheter.
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