OCTOPUS® TSMICS1 (UDI 00763000543693)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000543693), received between Apr 11, 2024 and Dec 1, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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 problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗