CLEARVIEWRecalls & reported problems across all models

We found 6 models of CLEARVIEW by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Feb 14, 2019 and Oct 15, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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

CLEARVIEW 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. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1803-2024 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗

2. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1794-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported CLEARVIEW problems

CLEARVIEW models

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

• CLEARVIEW® 31100

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  1 recall3 reports
• Clearview™ 22120

  LAVAGE, JET
  1 recall2 reports
• CLEARVIEW® 31125

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  1 recall2 reports
• CLEARVIEW® 31200

  CATHETER AND TIP, SUCTION
  1 recall0 reports
• Clearview™ 22150

  LAVAGE, JET
  3 reports
• CLEARVIEW® 31225

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  1 report

Recent CLEARVIEW adverse event reports

The 11 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING OF THE ARTERIOTOMY SHUNT WAS IMPROPERLY SEALED OVER THE DEVICE PRIOR TO USE, RESULTING IN A LOSS OF PRODUCT STERILITY. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE MATERIAL WAS PROTRUDING FROM THE STERILE AREA OF THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288703 ↗
• MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS ARTERIOTOMY SHUNT HAD THE BLUE TIP FALL OFF ALLEGEDLY WHILE IN THE PATIENT WAS IN OPERATING ROOM (OR). THE ORIGINAL INTENDED PROCEDURE WAS A CARDIOTHORACIC SURGERY. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20459915 ↗
• MalfunctionAug 22, 2024Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CLEARVIEW BLOWER MISTER, IT WAS REPORTED THAT NO CO2 GAS CAME OUT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NONE OF THE DEVICE TUBING OR THE DISTAL TIP APPEARED TO BE DAMAGED OR OCCLUDED. THERE WAS NO DAMAGE OR KINK IN THE TUBING. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER THINKS THE TIP WAS ON THE DEVICE WHEN THEY USED IT BUT THEY ARE NOT CERTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20026707 ↗
• InjuryJun 7, 2024Mechanical Problem; Unexpected Color; Mechanical Problem; Unexpected Color

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ARTERIOTOMY SHUNT, IT WAS REPORTED THAT THE DEVICE IS TRANSPARENT AND CLEAR IN COLOUR THUS MAKING IT DIFFICULT TO SEE AGAINST THE HEART AND CORONARY ARTERIES DURING A CORONARY ARTERY BYPASS GRAFT SURGERY. THE TRANSPARENT COLOUR MAKES THEM DIFFICULT TO WORK WITH AND A HAZARD DUE THE INABILITY TO SEE THE SHUNT APPROPRIATELY WHEN SITUATED ON THE HEART AND IS COVERED WITH BLOOD. ACCORDING TO THE CUSTOMER THE SHUNT'S ARE NOT BEING DESIGNED AS THEY PREVIOUSLY WERE THUS MAKING THE THREAD ON THEM TOO LARGE AND BULKY FOR FINE DELICATE WORKING ON THE CORONARY ARTERIES DURING A CORONARY ARTERY BYPASS GRAFTING PROCEDURE. THEY ARE TEARING THE ARTERIES AND NOT FLEXIBLE ENOUGH TO WORK WITH. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO FURTHER ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19481720 ↗
• MalfunctionMar 27, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CLEARVIEW BLOWER/MISTER, IT WAS REPORTED THAT THE IV PART OF THE DEVICE WAS BROK EN. USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985131 ↗
• MalfunctionMar 13, 2024Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A ARTERIOTOMY SHUNT, THE CUSTOMER REPORTED THAT DURING CORONARY AORTIC BYPASS SURGERY WITH A BEATING HEART BEFORE THE INSERTION OF THE SHUNT INTO THE CORONARY ARTERIOTOMY, SIMPLY BY TOUCHING IT WITH THE APPROPRIATE FORCEPS, THE DEVICE BROKE INTO TWO PARTS AT THE INSERTION POINT OF THE SILK THREAD. 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 18892386 ↗
• InjuryNov 9, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ARTERIOTOMY SHUNT, IT WAS REPORTED THAT THE SHUNT CAME APART IN THE VESSEL. THE CUSTOMER HAD TO TAKE DOWN THE ANASTOMOSIS, EXTEND IT AND RE-DO IT AS A LONG PATCH ANGIOPLASTY IN ORDER TO GET THE PIECE OF THE SHUNT OUT OF THE VESSEL.  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 18100053 ↗
• MalfunctionJun 20, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE PLASTIC TIP FROM THE CLEARVIEW BLOWER/MISTER DETACHED. THE TIP WAS LOCATED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION: CUSTOMER CONFIRMED THE TIP DID NOT FALL IN TO THE PATIENT AND WAS RETRIEVED. THE TIP HAS BEEN FOUND AND SENT BACK WITH THE DAMAGED PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162985 ↗
• MalfunctionJun 20, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CLEARVIEW BLOWER/MISTER KIT, THE TIP OF THE CLEARVIEW DETACHED DURING THE SURGERY. IT WAS NOTED THAT THE RECOMMENDATIONS OF THE IFU WERE FOLLOWED. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: THE EXACT TIME THAT THE TIP DETACHED WAS ASKED BUT UNKNOWN. THE DETACHED TIP WAS ON THE SCRUB TABLE WHEN THE CUSTOMER TRIED TO USE IT AGAIN. THE TIP DID NOT FALL INTO THE PATIENT'S BODY. THERE WAS NO DAMAGE TO THE DEVICE PACKAGING. NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162812 ↗
• MalfunctionMay 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE TIP OF CLEARVIEW BLOWER/MISTER WAS SEPARATED SUDDENLY DURING THE SURGERY. THEY SAID THEY DID NOT EXCEED A PRESSURE OF 60 PSI AND IT WAS FIRST CASE THAT THE TIP COME OFF. THEY COULD NOT FIND THE SEPARATED TIP AT THE TIME. THEY DID NOT HAVE ENOUGH TIME TO FIND THE TIP. SO THEY JUST CLOSED THE CHEST. THEY COULD NOT CONFIRM WHETHER THE TIP WAS IN THE PATIENT'S BODY OR NOT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10032120 ↗
• MalfunctionFeb 14, 2019Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED THE 31100 ARTERIOTOMY SHUNT BROKE DURING REMOVAL FROM THE PATIENT'S CORONARY ARTERY. THE SHUNT WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338517 ↗

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