Apparatus, Suction, Patient Care
FDA adverse event reports and recall history for apparatus, suction, patient care (product code DWM), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,120
- Deaths
- 24
- Injuries
- 253
- Malfunctions
- 737
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
- 2022-08-26Open, ClassifiedEnvironmental control
a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- 2014-12-12TerminatedProcess control
ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
- 2014-12-12TerminatedProcess control
ASEPT 600 ml Drainage Kit, Ref No. 622287, M7052 Product Usage: The ASEPT Drainage Kit is an accessory to be used to connect to the ASEPT Pleural or Peritoneal Drainage Catheter to drain fluid from the chest or abdomen.
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
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