Arthrex® AR-3653TSPRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867370067), received between Jun 5, 2024 and Jan 5, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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, 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Device Dislodged or Dislocated

  ON 16-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3653TSP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHOR AND TWO AR-3653SP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHORS FAILED TO DEPLOY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 12/24/2025: DURING A ROTATOR CUFF REPAIR PROCEDURE, ONE AR-3653TSP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHOR AND TWO AR-3653SP KNOTLESS 2.6 FIBERTAK RC SOFT ANCHORS PULLED OUT OF THE BONE BUT REMAINED INTACT, WITH NO FRAGMENTS LEFT BEHIND. THE PROCEDURE WAS COMPLETED USING AR-2324BCC BIOCOMPOSITE SWIVELOCK C SUTURE ANCHOR AND AR-2323BCC BIOCOMPOSITE SWIVELOCK SUTURE ANCHOR. THE EVENT RESULTED IN A 10¿15-MINUTE DELAY, REQUIRING ADDITIONAL ANESTHESIA FOR THE SAME DURATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23959166 ↗
• MalfunctionJul 1, 2024Use of Device Problem; Use of Device Problem

  ON 6/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3653TSP KNOTLESS 2.6 FIBERTAK RC SP SOFT ANCHOR SHUTTLING SUTURE WOULD NOT GO THROUGH THE ANCHOR AND WOULD NOT TENSION. THE ANCHOR REMAINED IN THE PATIENT, AND THE SUTURES WERE REMOVED. THE CASE WAS COMPLETED BY OPENING ANOTHER AR-3653TSP KNOTLESS 2.6 FIBERTAK WITH A SLIGHT DELAY IN THE CASE. NOTHING BROKE INSIDE THE PATIENT. THIS WAS DISCOVERED DURING AN ACHILLES SPEEDBRIDGE REPAIR PROCEDURE FOR A HAGLUND REMOVAL ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19649028 ↗
• MalfunctionJun 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 05/29/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3653TSP KNOTLESS 2.6 FIBERTAK RC PULLED OUT WHEN SHUTTING THE REPAIR STITCH FOR THE MEDIAL ROW COMPRESSION. THE CASE WAS COMPLETED BY IMPLANTING ANOTHER AR-3653TSP KNOTLESS 2.6 FIBERTAK RC. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19598813 ↗
• MalfunctionJun 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A RIGHT SHOULDER CUFF REPAIR SURGERY, THE ANCHOR JUST PULLED OUT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. THE SURGEON SWITCHED TO ANOTHER SURGICAL TECHNIQUE. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19466937 ↗