PASSER 11679Recalls & reported problems
Parcus Medical LLC · ProPass Suture Passer Needle · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816342025553), received between Aug 20, 2024 and Aug 20, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2024Break; Break
THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ANIKA OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ANIKA, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON (B)(6)2024 THE DISTRIBUTOR REPORTED THAT WHEN PERFORMING A SHOULDER PROCEDURE ON A MALE PATIENT OF UNKNOWN AGE THE PROPASS NEEDLE TIP BROKE OFF IN THE PATIENT'S SHOULDER. X-RAY IMAGES INDICATED THAT THE NEEDLE FRAGMENT REMAINED IN THE PATIENT AFTER AN ATTEMPT WAS MADE TO REMOVE IT. THE SURGEON REPORTED NO CURRENT PLAN TO REMOVE THE NEEDLE FRAGMENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN. ADDITIONAL INFORMATION WAS SOLICITED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20002097 ↗
Other Passer devices
- NA 7209485Smith & Nephew, Inc. · PASSER202 reports
- FIRSTPASS 22-4038Smith & Nephew, Inc. · PASSER189 reports
- FIRSTPASS 22-4035Smith & Nephew, Inc. · PASSER67 reports
- NanoPass CAT02298Stryker Corporation · PASSER15 reports
- NA 7210752Smith & Nephew, Inc. · PASSER13 reports
- ENDOBUTTON 014396Smith & Nephew, Inc. · PASSER10 reports
- SlingShot CAT02590Stryker Corporation · PASSER8 reports
- NA 014395Smith & Nephew, Inc. · PASSER5 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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