Aspen®Hubless Drain 360006Recalls & reported problems
Aspen Surgical Products, Inc. · Intended used for closed wound suction drainage · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840113209989), received between Nov 20, 2025 and Nov 20, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Output Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Output Problem1
- Use of Device Problem1
Patient problems
- Bacterial Infection1
- Granuloma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Use of Device Problem; Output Problem; Use of Device Problem; Output Problem
COMPLAINANT ALLEGES "PATIENT HAD THE FOLLOWING PROCEDURE ON (B)(6) 2025: NECK SCAR CONTRACTURE RELEASE, FLAP PLACEMENT, MICROLIPOSCULPTURE TO TRUNK, LIMITED FACIAL REJUVENATION. THE SURGEON REPORTED THAT THE RIGHT DRAIN WAS REMOVED ABOUT A WEEK LATER AND BECAUSE OF CONTINUED INDURATION AND A MASS, THE RIGHT LOWER NECK WAS EXPLORED. THIS SHOWED SOME UNUSUAL WET GRANULATION TISSUE. CULTURES WERE POSITIVE FOR MYCOBACTERIUM CHELONAE ALONG THE INTERNAL DRAIN TRACK."
Patient problems: Bacterial Infection; Granuloma
MAUDE report 23607744 ↗
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- Closed Wound Suction 0034610C. R. Bard, Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED62 reports
- CARDINAL HEALTH SU130-402DCardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall1 report
- CARDINAL HEALTH SU130-475Cardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall0 reports
- CARDINAL HEALTH SU130-403DCardinal Health 200, LLC · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 recall0 reports
- NA 1A8504Baxter International Inc. · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED50 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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