Arthrex® AR-7237-1Recalls & reported problems
Arthrex, Inc. · FIBERTAPE · Class 2 · Implant
Data updated Oct 16, 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 00888867120938), received between Dec 21, 2020 and Dec 21, 2020 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bradycardia1
- Erythema1
- Extreme Exhaustion1
- Fever1
- Inflammation1
- Pain1
- Swelling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED FROM ON HOSPITAL TO ANOTHER FOR LIGAMENT STABILISATION AT THE ELBOW. DURING THE PROCEDURE THE PATIENT WAS TREATED WITH TWO PUSHLOCK BIOCOMPOSITE 3,5MM AND A FIBERTAPE. POSTOPERATIVE THE PATIENT CONDITIONS GOT INTERMITTENTLY WORSE. THE PATIENT COMPLAINT ABOUT HAVING A LITTLE PAIN, FEVER AND IS FEELING EXHAUSTED. IT WAS FURTHER REPORTED THAT THE HEART PERFORMANCE DECREASED TO 45%. OTHER SIGNS OF INFLAMMATION SUCH AS SWELLING, REDNESS AND HEAT ARE NOT PRESENT ACCORDING TO THE MEDICAL STAFF. THE PATIENT WAS DIAGNOSED BUT SO FAR NO CAUSE COULD BE FOUND THEREFORE THE HOSPITAL ASSUMES THAT THE ALLERGIC REACTION WAS CAUSED BY THE FIBERTAPE. THE PATIENT IS CURRENTLY TREATED CONSERVATIVELY.
Patient problems: Bradycardia; Erythema; Extreme Exhaustion; Fever; Inflammation; Pain; Swelling
MAUDE report 11046854 ↗
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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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