Arthrex® AR-7288TRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867369863), received between May 24, 2021 and May 12, 2025 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (7 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 4/9/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT PROCEDURE ON (B)(6) 2025, DURING WHICH A FIBERTAPE STERNAL CLOSURE WAS USED. THE PATIENT THEN PRESENTED WITH A CORYNEBACTERIUM AMYCOLATUM STERNAL WOUND INFECTION, REQUIRING ADDITIONAL SURGERY. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 4/16/2025: THE PATIENT UNDERWENT INITIAL SURGERY ON (B)(6) 2025, DURING WHICH AN AR-7288 FIBERTAPE STERNAL CLOSURE, AN AR-7289T TIGERTAPE STERNAL CLOSURE, AND AN AR-7288T TIGERTAPE STERNAL CLOSURE WERE IMPLANTED. POSTOPERATIVELY, ON (B)(6) 2025, THE PATIENT DEVELOPED STERNAL WOUND DRAINAGE, GAS ACCUMULATION, AND FLUID COLLECTION EXTENDING TO THE MEDIASTINUM. TO ADDRESS THESE COMPLICATIONS, THE PATIENT REQUIRED MULTIPLE IRRIGATION AND DEBRIDEMENT PROCEDURES, ALONG WITH WOUND VACUUM-ASSISTED CLOSURES, PERFORMED ON (B)(6) 2025. FOLLOWING THESE INTERVENTIONS, THE PATIENT UNDERWENT A BILATERAL PECTORALIS FLAP PROCEDURE FOR CHEST CLOSURE. DURING AN ADDITIONAL SURGICAL PROCEDURE, THE IMPLANTS WERE EXPLANTED; HOWEVER, THE SPECIFIC IMPLANTS REMOVED, AND THE EXACT DATE OF THE S

  Patient problems: Bacterial Infection; Pain; Wound Infection

  MAUDE report 22004280 ↗
• InjuryMay 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 4/9/2025, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT AN AORTIC VALVE REPLACEMENT, TISSUE AND CORONARY ARTERY BYPASS GRAFT, AND REPAIR TRICUSPID VALVE PROCEDURE IN MARCH OF 2025. THE PATIENT'S STERNAL CLOSURE WAS ACHIEVED WITH AN AR-7288 FIBERTAPE STERNAL CLOSURE. THE PATIENT THEN PRESENTED WITH A STERNAL WOUND INFECTION, REQUIRING ADDITIONAL SURGERY. SURGICAL CULTURES REVEALED CORYNEBACTERIUM AMYCOLATUM. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 4/16/2025: THE FACILITY REPRESENTATIVE CONFIRMED THAT, IN ADDITION TO THE AR-7288 FIBERTAPE STERNAL CLOSURE, AN AR-7289T TIGERTAPE STERNAL CLOSURE, AND AN AR-7288T TIGERTAPE STERNAL CLOSURE WERE IMPLANTED DURING THE INITIAL SURGERY ON (B)(6) 2025. THE PATIENT BEGAN EXPERIENCING SYMPTOMS ON 3/14/2025, INCLUDING CHEST PAIN, CHEST WALL ABSCESS, AND MEDIASTINITIS. THE INFECTION, IDENTIFIED AS CORYNEBACTERIUM AMYCOLATUM, REQUIRED MULTIPLE TREATMENTS, INCLUDING DEBRIDEMENT AND IRRIGATION OF THE CHEST, A PECTORALIS MUSCLE FLAP FOR CLOSURE, AND WOUND VACUUM-ASSISTED CLOSURE. THESE INTERVENTIONS WERE PERFORMED ON (B)(6) 2025. DURING AN ADDITIONA

  Patient problems: Bacterial Infection; Pain; Wound Infection

  MAUDE report 21993373 ↗
• InjuryApr 28, 2025Biocompatibility; Patient Device Interaction Problem; Biocompatibility; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 4/16/2025: THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2025, DURING WHICH AN AR-7288 FIBERTAPE STERNAL CLOSURE, AN AR-7288T FIBERTAPE STERNAL CLOSURE, AND AN AR-7289T TIGERTAPE STERNAL CLOSURE WERE IMPLANTED. AROUND (B)(6) 2025, THE PATIENT DEVELOPED PURULENT DRAINAGE AND ERYTHEMA AT THE CHEST INCISION SITE. THE INFECTION WAS MANAGED WITH IV ANTIBIOTICS, MULTIPLE IRRIGATION AND DEBRIDEMENT PROCEDURES, WOUND VACUUM-ASSISTED CLOSURES, AND A PECTORAL FLAP FOR CHEST CLOSURE. THE PATIENT UNDERWENT PROCEDURES ON (B)(6) 2025 TO ADDRESS THE ONGOING INFECTION. DURING A SUBSEQUENT SURGICAL INTERVENTION, THE AR-7288 FIBERTAPE STERNAL CLOSURE AND AR-7289T TIGERTAPE STERNAL CLOSURE WERE EXPLANTED. AS OF (B)(6) 2025, THE PATIENT REMAINS HOSPITALIZED AND CONTINUES RECEIVING IV VANCOMYCIN.

  Patient problems: Erythema; Purulent Discharge; Wound Infection

  MAUDE report 21917688 ↗
• InjuryApr 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 4/16/2025: THE INITIAL SURGERY TOOK PLACE ON (B)(6) 2025, DURING WHICH FOUR AR-7289T AND THREE AR-7288 IMPLANTS WERE PLACED. AROUND (B)(6) 2025, THE PATIENT BEGAN EXPERIENCING STERNAL WOUND REDNESS, PURULENT DRAINAGE, AND INVASIVE FUNGAL DISEASE. TO ADDRESS THESE COMPLICATIONS, THE PATIENT UNDERWENT MULTIPLE IRRIGATION AND DEBRIDEMENT PROCEDURES ON (B)(6) 2025, FOLLOWED BY BILATERAL PECTORALIS ADVANCEMENT FLAPS FOR CHEST CLOSURE. DURING AN ADDITIONAL SURGICAL PROCEDURE, THE IMPLANTS WERE EXPLANTED; HOWEVER, THE SPECIFIC IMPLANTS REMOVED, AND THE EXACT DATE OF THE SURGERY REMAIN UNCLEAR. THE PATIENT WAS READMITTED ON (B)(6) 2025 FOR A CURRENT STERNAL WOUND INFECTION.

  Patient problems: Wound Infection

  MAUDE report 21912368 ↗
• MalfunctionJul 12, 2024Positioning Failure; Positioning Failure

  ON 06/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT SEVEN AR-7288T FIBERTAPE STERNAL CLOSURE APPEARED LOOSE AND UNRAVELED. THE SURGEON ATTEMPTED TO USE THEM; HOWEVER, THEY TORE AN INCH OR TWO BEHIND THE NEEDLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 7/1/2024: THIS WAS DISCOVERED DURING A CABG PROCEDURE. THE CASE WAS COMPLETED BY REPLACING ALL THE AR-7288T FIBERTAPE STERNAL CLOSURE WITH AR-7288 FIBERTAPE STERNAL CLOSURE. EVERYTHING WAS REMOVED FROM THE PATIENT AND THE CASE WAS DELAYED BETWEEN TWO TO THREE MINUTES. THE SALES REPRESENTATIVE DOES NOT KNOW IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730158 ↗
• MalfunctionJul 12, 2024Positioning Failure; Positioning Failure

  ON 06/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT SEVEN AR-7288T FIBERTAPE STERNAL CLOSURE APPEARED LOOSE AND UNRAVELED. THE SURGEON ATTEMPTED TO USE THEM; HOWEVER, THEY TORE AN INCH OR TWO BEHIND THE NEEDLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 7/1/2024: THIS WAS DISCOVERED DURING A CABG PROCEDURE. THE CASE WAS COMPLETED BY REPLACING ALL THE AR-7288T FIBERTAPE STERNAL CLOSURE WITH AR-7288 FIBERTAPE STERNAL CLOSURE. EVERYTHING WAS REMOVED FROM THE PATIENT AND THE CASE WAS DELAYED BETWEEN TWO TO THREE MINUTES. THE SALES REPRESENTATIVE DOES NOT KNOW IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730109 ↗
• MalfunctionJul 12, 2024Positioning Failure; Positioning Failure

  ON 06/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT SEVEN AR-7288T FIBERTAPE STERNAL CLOSURE APPEARED LOOSE AND UNRAVELED. THE SURGEON ATTEMPTED TO USE THEM; HOWEVER, THEY TORE AN INCH OR TWO BEHIND THE NEEDLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 7/1/2024: THIS WAS DISCOVERED DURING A CABG PROCEDURE. THE CASE WAS COMPLETED BY REPLACING ALL THE AR-7288T FIBERTAPE STERNAL CLOSURE WITH AR-7288 FIBERTAPE STERNAL CLOSURE. EVERYTHING WAS REMOVED FROM THE PATIENT AND THE CASE WAS DELAYED BETWEEN TWO TO THREE MINUTES. THE SALES REPRESENTATIVE DOES NOT KNOW IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729998 ↗
• MalfunctionJul 12, 2024Positioning Failure; Positioning Failure

  ON 06/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT SEVEN AR-7288T FIBERTAPE STERNAL CLOSURE APPEARED LOOSE AND UNRAVELED. THE SURGEON ATTEMPTED TO USE THEM; HOWEVER, THEY TORE AN INCH OR TWO BEHIND THE NEEDLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 7/1/2024: THIS WAS DISCOVERED DURING A CABG PROCEDURE. THE CASE WAS COMPLETED BY REPLACING ALL THE AR-7288T FIBERTAPE STERNAL CLOSURE WITH AR-7288 FIBERTAPE STERNAL CLOSURE. EVERYTHING WAS REMOVED FROM THE PATIENT AND THE CASE WAS DELAYED BETWEEN TWO TO THREE MINUTES. THE SALES REPRESENTATIVE DOES NOT KNOW IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729965 ↗
• MalfunctionJul 12, 2024Positioning Failure; Positioning Failure

  ON 06/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT SEVEN AR-7288T FIBERTAPE STERNAL CLOSURE APPEARED LOOSE AND UNRAVELED. THE SURGEON ATTEMPTED TO USE THEM; HOWEVER, THEY TORE AN INCH OR TWO BEHIND THE NEEDLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 7/1/2024: THIS WAS DISCOVERED DURING A CABG PROCEDURE. THE CASE WAS COMPLETED BY REPLACING ALL THE AR-7288T FIBERTAPE STERNAL CLOSURE WITH AR-7288 FIBERTAPE STERNAL CLOSURE. EVERYTHING WAS REMOVED FROM THE PATIENT AND THE CASE WAS DELAYED BETWEEN TWO TO THREE MINUTES. THE SALES REPRESENTATIVE DOES NOT KNOW IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729737 ↗
• MalfunctionJul 12, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT SEVEN AR-7288T FIBERTAPE STERNAL CLOSURE APPEARED LOOSE AND UNRAVELED. THE SURGEON ATTEMPTED TO USE THEM; HOWEVER, THEY TORE AN INCH OR TWO BEHIND THE NEEDLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 7/1/2024: THIS WAS DISCOVERED DURING A CABG PROCEDURE. THE CASE WAS COMPLETED BY REPLACING ALL THE AR-7288T FIBERTAPE STERNAL CLOSURE WITH AR-7288 FIBERTAPE STERNAL CLOSURE. EVERYTHING WAS REMOVED FROM THE PATIENT AND THE CASE WAS DELAYED BETWEEN TWO TO THREE MINUTES. THE SALES REPRESENTATIVE DOES NOT KNOW IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729579 ↗
• MalfunctionJul 12, 2024Positioning Failure; Positioning Failure

  ON 06/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT SEVEN AR-7288T FIBERTAPE STERNAL CLOSURE APPEARED LOOSE AND UNRAVELED. THE SURGEON ATTEMPTED TO USE THEM; HOWEVER, THEY TORE AN INCH OR TWO BEHIND THE NEEDLE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 7/1/2024: THIS WAS DISCOVERED DURING A CABG PROCEDURE. THE CASE WAS COMPLETED BY REPLACING ALL THE AR-7288T FIBERTAPE STERNAL CLOSURE WITH AR-7288 FIBERTAPE STERNAL CLOSURE. EVERYTHING WAS REMOVED FROM THE PATIENT AND THE CASE WAS DELAYED BETWEEN TWO TO THREE MINUTES. THE SALES REPRESENTATIVE DOES NOT KNOW IF ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729351 ↗
• MalfunctionMay 24, 2021Break

  IT WAS REPORTED THAT THE NEEDLE BROKE OFF THE AR-7288T SUTURE WHEN THE SURGEON WAS PASSING IT THROUGH THE STERNAL SPACE. NOTHING WAS LEFT IN THE PATIENT AND THE CASE WAS COMPLETED WITH A NEW SUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872393 ↗