OCTOPUS® TS2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169668911), received between Oct 19, 2021 and Jan 22, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 12, 2026Open, Classified

   During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.

   Z-2575-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT THERE WAS DAMAGE OBSERVED TO THE OCTOPUS TISSUE STABILIZER PACKAGING PRIOR TO USE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PACKAGE HAD NOT BEEN OPENED AND THE INNER PACKAGE WAS DAMAGED. THE STERILE BARRIER WAS DAMAGED. NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143309 ↗
• MalfunctionJan 22, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A OCTOPUS EVOLUTION TISSUE STABILIZER, IT WAS REPORTED THAT BEFORE THE OFF-PUMP BYPASS SURGERY, THE INNER PACKAGING WAS OBSERVED TO BE DAMAGED WHEN THE OUTER PACKAGING OF THE DEVICE WAS OPENED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WERE NO MISSING DEVICES/COMPONENTS IN THE PACKAGE. THE STERILE SEAL WAS NOT INTACT. THE DEVICE WAS NOT SEALED/LOCATED IN THE SEAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143299 ↗
• MalfunctionJan 21, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN OCTOPUS TISSUE STABILIZER, THE CUSTOMER REPORTED THAT AFTER OPENING THE PRODUCT, IT WAS FOUND THAT THERE WAS A GAP IN THE STERILE PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE SEAL WAS NOT INTACT. THE DEVICE WAS NOT SEALED/LOCATED IN THE 'SEAL'.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133028 ↗
• MalfunctionJul 25, 2025Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN OCTOPUS TISSUE STABILIZER, IT WAS REPORTED THAT THE DEVICE BROKE WHEN THE SURGEON WAS ADJUSTING THE ANGLE OF THE SUCTION CUP IN FRONT OF THE TISSUE FIXATOR. THE DEVICE WAS USED IN THE EXTRACARDIAC CORONARY ARTERY BYPASS SURGERY TO FIX THE HEART AND FACILITATE THE SURGEON TO PERFORM THE OPERATION. IN THE OFF-PUMP CORONARY ARTERY BYPASS SURGERY, THE PATIENT HAD A HIGH SURGICAL RISK. IF THE METAL OF THE SUCTION CUP BROKE, THE HEART COULD NOT BE FIXED, AND CORONARY BLEEDING WAS EASY TO OCCUR DURING THE ANASTOMOSIS, ENDANGERING THE PATIENT'S LIFE. THE DEVICE WAS REPLACED URGENTLY TO COMPLETE THE PROCEDURE AND CONTINUED TO FREE THE CORONARY ARTERY VESSELS TO SUCCESSFULLY COMPLETE THE OPERATION. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607422 ↗
• MalfunctionJul 17, 2025Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A TISSUE OCTOPUS STABILIZER, IT WAS REPORTED THAT A FRACTURE OCCURRED AT THE TIP DURING THE OPERATION. THE METAL AT THE TIP OF THE FIXATOR (BELOW THE SUCTION CUP AND ABOVE THE NEGATIVE PRESSURE SUCTION TUBE) WAS BROKEN. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529325 ↗
• MalfunctionJan 29, 2025Material Separation; Material Deformation; Material Separation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE OCTOPUS TISSUE STABILIZER, A PIECE OF PLASTIC BROKE OFF THE DEVICE. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21262935 ↗
• MalfunctionApr 11, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN OCTOPUS STABILIZER, IT WAS REPORTED THAT HALF OF THE TIP OF THE DEVICE BROKE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING, AND OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED. THE TIP DID NOT FALL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19086075 ↗
• MalfunctionMar 19, 2024Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN OCTOPUS TISSUE STABILIZER, IT WAS REPORTED THAT DURING THE OPERATION, THE FIXATOR AND CHEST SUPPORT WERE NOT FIRM AND WAS WOBBLY. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18932268 ↗
• MalfunctionJan 29, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN OCTOPUS TISSUE STABILIZER, THE CUSTOMER REPORTED THAT THEY OBSERVED A CRACK/BREAKAGE AT THE U JUNCTION ON THE PODS WHEN THE DEVICE WAS OPENED. AS A RESULT, THE CUSTOMER COULD NOT USE THE DEVICE IN THE SURGERY. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE OUTER PACKAGING OR STERILE BARRIER AND NO OTHER DEVICES WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18595576 ↗
• MalfunctionNov 20, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN OCTOPUS TISSUE STABILIZER, IT WAS REPORTED THAT AFTER THE THORACOTOMY AND ALL P REPARATIONS WERE COMPLETED FOR THE OPERATION, THE CUSTOMER OBSERVED THAT WHEN THE FIXATOR WAS USED FOR FIXATION THE JOINT BETWEEN THE TIP NEGATIVE SUCTION TUBE AND THE FIXATOR BROKE AND FELL OFF. THE DEVICE FIXATOR WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER CONFIRMED THAT THE BROKEN/DETACHED PART DID NOT FALL INTO THE PATIENT¿S BODY. AFTER FALLING OFF, THE CUSTOMER LEFT THE OPERATING TABLE IN TIME TO AVOID IT FALLING INTO THE PATIENT'S BODY. THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). THERE WERE NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER ALSO DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18168857 ↗
• MalfunctionJun 20, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A TISSUE STABILIZER OCTOPUS, IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STABILIZER WAS MOUNTED ON THE WALL OF HEART AND VACUUM WAS APPLIED. THE SURGEON WAS ABOUT TO START SUTURING THE BYPASS BUT THE STABILIZER BROKE. THE TISSUE STABILIZER WAS NOT NOTED TO BE LOOSE PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17161800 ↗
• MalfunctionJun 12, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS OCTOPUS TISSUE STABILIZER, THE TISSUE STABILIZER FRACTURED (FIXING CLIP, TOWER, HOOK LOCK). THE DEVICE WAS NOT REPLACED, CUSTOMER STATED THERE WAS NO NEED. IT WAS ASKED IF THERE WERE ANY ADVERSE PATIENT EFFECTS; HOWEVER, THIS INFORMATION WAS UNAVAILABLE. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. IT WAS ASKED IF ANY PART OF THE TISSUE STABILIZER FALL INTO THE PATIENT; HOWEVER, THIS INFORMATION WAS UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105497 ↗
• MalfunctionFeb 8, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN OCTOPUS TISSUE STABILIZER, THE CUSTOMER REPORTED THAT THE CLIP OF THE TISSUE STABILIZER WAS DAMAGED. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO DAMAGE TO THE PACKAGING, OUTER BOX, INNER PACKAGING OR STERILE BARRIER. NO OTHER DEVICES WERE DAMAGED IN THE SAME BOX/SHIPPING CONTAINER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16324904 ↗
• MalfunctionNov 11, 2022Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN OCTOPUS EVOLUTION TISSUE STABILIZER, IT WAS REPORTED THAT WHEN THE PRODUCT WAS OPENED WHILE PREPARING FOR THE SURGERY, THE CUSTOMER NOTICED THAT IT WAS BROKEN. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE HOOK THAT HOLDS THE STERNAL RETRACTOR WAS BROKEN. THERE WAS NO DAMAGE TO THE PACKAGING (OUTER BOX, INNER PACKAGING OR STERILE BARRIER). NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15778746 ↗
• MalfunctionOct 19, 2021Fracture; Mechanical Problem; Fracture; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS OCTOPUS EVOLUTION TISSUE STABILIZER DEVICE THE HEADLINK FELL OFF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12655084 ↗