Closed Wound SuctionRecalls & reported problems across all models
C. R. Bard, Inc. · 24 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 783
- Deaths reported
- 0
- Injuries reported
- 72
- Recalls
- 0
We found 24 models of Closed Wound Suction by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 783 adverse event reports in the FDA's MAUDE database, received between Mar 29, 2017 and Sep 30, 2026 — classified as 72 injuries, 711 malfunctions.
The most frequently reported specific device problem is “Disconnection” (151 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Closed Wound Suction problems
Device problems
- Disconnection151
- Dull, Blunt102
- Device Contamination with Chemical or Other Material92
- Break74
- Material Fragmentation60
- Suction Failure51
- Suction Problem45
- Fluid/Blood Leak32
Patient problems
- No Clinical Signs, Symptoms or Conditions398
- No Consequences Or Impact To Patient230
- No Known Impact Or Consequence To Patient216
- No Patient Involvement68
- Foreign Body In Patient49
- No Information26
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available20
- No Code Available15
Closed Wound Suction models
24 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Closed Wound Suction 0043610APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED303 reports
- Closed Wound Suction 0070740APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED192 reports
- Closed Wound Suction 0034610APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED62 reports
- Closed Wound Suction 0043650APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED45 reports
- Closed Wound Suction 0043600APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED35 reports
- Closed Wound Suction V0043610APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED29 reports
- Closed Wound Suction 0043620APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED17 reports
- Closed Wound Suction 0043630APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED15 reports
- Closed Wound Suction 0071200APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED15 reports
- Closed Wound Suction 0070850APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED11 reports
- Closed Wound Suction 0043660APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED10 reports
- Closed Wound Suction 0070900APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED10 reports
- Closed Wound Suction 0071430APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED7 reports
- Closed Wound Suction V0070740APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED7 reports
- Closed Wound Suction 0071360APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED4 reports
- Closed Wound Suction 0071440APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED4 reports
- Closed Wound Suction 0034600APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED3 reports
- Closed Wound Suction 0034630APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED3 reports
- Closed Wound Suction 0070400APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED3 reports
- Closed Wound Suction 0043670APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED2 reports
- Closed Wound Suction 0071370APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED2 reports
- Closed Wound Suction 0072360APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED2 reports
- Closed Wound Suction 0072430APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 report
- Closed Wound Suction 0072440APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 report
Recent Closed Wound Suction adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Dull, Blunt
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950945 ↗MalfunctionSep 30, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950944 ↗MalfunctionSep 30, 2026Disconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950943 ↗MalfunctionSep 30, 2026Dull, Blunt
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950942 ↗MalfunctionSep 10, 2026Dull, Blunt
It was reported that customer had concern in OR with two evacuators also felt the evacuators were dull than in the past. Material 0043610 and Material 0043620.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50721014 ↗MalfunctionSep 10, 2026Dull, Blunt
It was reported that customer had concern in the Operating Room with two evacuators. Also felt the evacuators were dull than in the past. Material 0043610 and Material 0043620.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716248 ↗MalfunctionJul 30, 2026Decrease in Suction
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50085782 ↗MalfunctionJul 16, 2026Incorrect Measurement
THE CUSTOMER REPORTED A BD HEMOVAC DRAINS POSSIBLE DESIGN OR MANUFACTURING CHANGE. THEY STATED THAT, IN THE PAST, THE DRAIN PERFORATIONS EXTENDED TO THE END OF THE TUBING; HOWEVER, RECENTLY RECEIVED PRODUCTS HAD PERFORATIONS LOCATED IN THE MIDDLE SECTION OF THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25849848 ↗MalfunctionJul 14, 2026Fitting Problem
IT WAS REPORTED THAT THE WOUND DRAINS WERE NOT SEALING BETWEEN THE EVACUATOR AND THE DRAIN, MAKING IT UNABLE TO COMPLETE THE TASK, AND ALSO MAKING THE PRODUCT TO PERFORM NOT AS INTENDED. LOT NGLN1260.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25812540 ↗MalfunctionJul 14, 2026Fitting Problem
IT WAS REPORTED THAT THE WOUND DRAINS WERE NOT SEALING BETWEEN THE EVACUATOR AND THE DRAIN, MAKING IT UNABLE TO COMPLETE THE TASK, AND ALSO MAKING THE PRODUCT TO PERFORM NOT AS INTENDED. LOT NGKZ1251.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25812533 ↗MalfunctionJun 12, 2026Disconnection
IT WAS REPORTED THAT AT 07:30 THE PATIENTS HEMOVAC DRAIN APPEARED TO NOT BE PRIMED. ATTEMPTED TO PRIME THE HEMOVAC. AFTER ATTEMPTING TO PRIME IT TOOK THE HEMOVAC LESS THAN 2 SECONDS TO COMPLETELY REFILL WITH AIR. WHEN CHECKING THE LINE, THEY FOUND THAT THE DRAIN WAS COMPLETELY DISCONNECTED WITH BOTH ENDS UNDERNEATH THE PATIENT WITH DRAINAGE ON THE PATIENTS BEDDING AND GOWN. THEY THEN APPLIED STERILE GAUZE TO THE END OF THE TUBE AND CLAMPED THE LINE. PATIENT EXPERIENCED UNEXPECTED AND PROLONGED CARE.
Patient problems: Exposure to Body Fluids
MAUDE report 25493461 ↗MalfunctionJun 11, 2026Disconnection
IT WAS REPORTED THAT THE HEMOVAC DRAIN WAS DISCONNECTED ON THE PORT WHEN PATIENT MOVED AND HAD THE BLOOD SATURATING THE LINENS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25480177 ↗MalfunctionJun 5, 2026Disconnection
IT WAS REPORTED THAT HEMOVAC TUBING FOR RIGHT BACK WOUND DRAIN CAME DISCONNECTED AFTER WORKING WITH PHYSIOTHERAPY, DISCONNECTED AT Y SITE. PATIENT EXPERIENCED UNEXPECTED OR PROLONGED CARE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25412866 ↗MalfunctionMay 28, 2026Disconnection
IT WAS REPORTED BY CUSTOMER THAT THE 400 CC EVACUATION SYSTEM WITH 18 INCH POLYVINYL CHLORIDE TUBING AND TROCAR TUBING DISCONNECTION CAUSING BLOOD TO DRAIN ON THE PATIENT AND BED.
Patient problems: Exposure to Body Fluids; No Clinical Signs, Symptoms or Conditions
MAUDE report 25325538 ↗MalfunctionMay 22, 2026Disconnection
IT WAS REPORTED THAT THEY WERE NOTICED THE WOUND DRAIN RESERVOIRS ARE FELL OFF THE DRAIN TUBING, WHICH THEN LEADS TO DRAINS LEAKING, INACCURATE I & O MEASUREMENTS, AND A DIRECT PATH FOR INFECTION FROM AN OPEN DRAIN TUBE TO THE SURGICAL SITE. THEY HAD BEEN HAVING THAT ISSUE ON AND OFF FOR A WHILE WITH OUR DRAIN SO IF THEY COULD HAVE SOME HELP INVESTIGATING THE ISSUE WITH OUR DRAIN THAT WOULD BE HELPFUL. THEY ARE VERY OPEN TO GETTING ANY EXTRA TRAINING ON THAT OR ADVICE IF THEY WERE NOT USED THAT CORRECTLY WHICH WAS LEADING TO THOSE ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25262611 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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