OCTOPUSRecalls & reported problems across all models

We found 5 models of OCTOPUS by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2021 and Jan 28, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (8 reports).

4 FDA recall records name at least one of these models by its device identifier, 4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

OCTOPUS recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-2577-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-2576-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

4. Jan 13, 2026Open, Classified

   During the manufacturing, 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-1473-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported OCTOPUS problems

OCTOPUS models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• OCTOPUS® TS2000

  stabilizer,heart
  1 recall15 reports
• OCTOPUS® TSMICS1

  Stabilizer, heart
  1 recall5 reports
• OCTOPUS® TS2500

  stabilizer,heart
  1 recall3 reports
• OCTOPUS® 29400

  Stabilizer, heart
  1 recall0 reports
• OCTOPUS® TSMICS1

  stabilizer,heart
  1 report

Recent OCTOPUS adverse event reports

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

• MalfunctionJan 28, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN OCTOPUS TISSUE STABILIZER, IT WAS REPORTED THAT THE STERILE BOX OF THE PRODUCT WAS ALREADY OPEN, SO THE CUSTOMER QUESTIONED THE STERILITY OF THE PRODUCT. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE NO MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE STERILE PACKAGE WAS NOT PROPERLY CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198624 ↗
• 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 ↗
• MalfunctionJan 19, 2026Delivered as Unsterile Product

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN OCTOPUS TISSUE STABILIZER, IT WAS REPORTED THAT WHEN RECEIVING GOODS FROM THE CARRIER'S FORWARDER FROM MEDTRONIC TO AN PHA. THE CUSTOMER OBSERVED THAT 01 BOX HAD DAMAGED PACKAGING, THE PRODUCT INSIDE HAD BLACK STAINS DUE TO DAMAGED OUTER SHELL. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PACKAGE IS INTACT, CUSTOMER KEPT THE DEFECTIVE PACKAGE AS IT WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108300 ↗
• MalfunctionDec 1, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS AN ALLEGED PRODUCT ISSUE INVOLVING THE OCTOPUS TISSUE STABILIZER, SPECIFICALLY A BREAKAGE OF THE SUCTION CUP DURING USE. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678724 ↗
• MalfunctionAug 7, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE OPENING OF THE OCTOPUS NUVO TISSUE STABILIZER, THE BULLET TIP WAS NOT SEATED IN THE SLOT AND POPPED OUT, FLYING OUT OF THE PACKAGING AND LANDING ON THE FLOOR DURING USE. THE BULLET TIP DID NOT FALL INTO THE PATIENT. ANOTHER DEVICE WAS OPENED TO OBTAIN A REPLACEMENT BULLET TIP, AND THE ORIGINAL DEVICE WAS USED WITH THE BULLET TIP FROM THE SECOND DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22735793 ↗
• 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 ↗
• MalfunctionApr 29, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A MIDCAB (MINIMALLY INVASIVE DIRECT CORONARY ARTERY BYPASS) SURGERY, THE OCTOPUS STABILIZER DEVICE BROKE WHILE THE SURGEON WAS ATTEMPTING TO SHAPE IT PRIOR TO PLACING IT ON THE PATIENT'S HEART FOR STABILIZATION. THERE WAS A BREAK AT THE PROXIMAL END OF THE METAL PORTION OF THE SUCTION PODS. THE PRODUCT NEVER TOUCHED THE PATIENT, AND ANOTHER PRODUCT OF THE SAME TYPE WAS OPENED AND SUCCESSFULLY USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927008 ↗
• 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 ↗
• MalfunctionAug 6, 2024Suction Problem; Material Deformation; Suction Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS OCTOPUS TISSUE STABILIZER HAD NO SUCTION AND DAMAGED TUBING ALONG THE SUCTION LINE. THE CUSTOMER STATED THAT THE DAMAGE WAS AT THE ATTACHMENT OF THE SUCTION HEADLINK. THE TUBING BROKE ACROSS THE CIRCUMFERENCE OF THE TUBING. THE  SUCTION PODS WERE NOT OBSTRUCTED. THE SUCTION HEAD WAS NOT OBSTRUCTED OR DAMAGED. THE HEADLINK WAS NOT REPOSITIONED IN THE CASE. SEE ATTACHED PHOTO. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. THE CUSTOMER STARTED TO APPLY THE HEADLINK TO POSITION IT AND TUBING WAS BROKEN OFF THE HEADLINK SUCTION. THE CUSTOMER HAS DONE MANY CASES AND STATED THAT THE DEVICE WAS NOT MISHANDLED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER PLACED TOO MUCH TENSION ON THE TUBING AND IT BROKE OFF WHILE ATTACHING THE HEADLINK ONTO THE STABILIZING BAR. THE TUBING BECAME STRETCHED DUE TO TIGHT CHESTS AND WAS NOT DUE TO A FAULTY DEVICE OR SHIPPING DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19916480 ↗
• MalfunctionApr 11, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN OCTOPUS NUVO TISSUE STABILIZER, IT WAS REPORTED THAT THERE WAS A DEFECT WHEN THE CUSTOMER TRIED TO USE THE DEVICE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER TRIED TO USE THE DEVICE BUT IT WAS OBSERVED THAT THE HEAD WAS BROKEN. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT 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 19086514 ↗
• 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 ↗

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