Surgipro ll VP-902-XRecalls & reported problems

Summary

The FDA's MAUDE database contains 71 adverse event reports that list this exact device (DI 10884521039568), received between Oct 25, 2017 and Aug 13, 2026 — classified as 1 injury, 70 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (41 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 18, 2026.

Recalls naming this device

1. Dec 2, 2022Class IIOpen, Classified

   Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in cases where there is direct patient contact

   Z-1180-2023 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 71 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232033 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50232007 ↗
• MalfunctionApr 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON USED THE THREAD, IT BECAME LOOSE SEVERAL TIMES (AT LEAST FOUR), AND THE THREAD DETACHED FROM THE NEEDLE IN THE MIDDLE OF THE ANASTOMOSIS. THE NEEDLE DID NOT FALL INTO THE PATIENT¿S CAVITY. RESUMPTION OF A THREAD AND SUTURING WAS MADE IN 2 THREADS INSTEAD OF ONE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926759 ↗
• MalfunctionApr 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON USED THE THREAD, IT BECAME LOOSE SEVERAL TIMES (AT LEAST FOUR), AND THE THREAD DETACHED FROM THE NEEDLE IN THE MIDDLE OF THE ANASTOMOSIS. THE NEEDLE DID NOT FALL INTO THE PATIENT¿S CAVITY. RESUMPTION OF A THREAD AND SUTURING WAS MADE IN 2 THREADS INSTEAD OF ONE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926633 ↗
• MalfunctionApr 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN OPEN SURGERY, WHEN THE SURGEON USED THE THREAD, IT BECAME LOOSE SEVERAL TIMES (AT LEAST FOUR), AND THE THREAD DETACHED FROM THE NEEDLE IN THE MIDDLE OF THE ANASTOMOSIS. THE NEEDLE DID NOT FALL INTO THE PATIENT¿S CAVITY. RESUMPTION OF A THREAD AND SUTURING WAS MADE IN 2 THREADS INSTEAD OF ONE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24926298 ↗
• MalfunctionApr 17, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SURGEON USED THE THREAD, IT BECAME LOOSE SEVERAL TIMES (AT LEAST FOUR), AND THE THREAD DETACHED FROM THE NEEDLE IN THE MIDDLE OF THE ANASTOMOSIS. THE NEEDLE DID NOT FALL INTO THE PATIENT¿S CAVITY. RESUMPTION OF A THREAD AND SUTURING WAS MADE IN TWO THREADS INSTEAD OF ONE. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911661 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT DURING AN ANASTOMOSIS PROCEDURE, TWO THREADS OF THE SUTURE BROKE CONSECUTIVELY WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401448 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT DURING AN ANASTOMOSIS PROCEDURE, TWO THREADS OF THE SUTURE BROKE CONSECUTIVELY WHILE SUTURING. AN ADDITIONAL NEW SUTURE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401329 ↗
• MalfunctionJan 17, 2026Dull, Blunt; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING CARDIOPULMONARY BYPASS CORONARY ARTERY BYPASS SURGERY, WHEN ANASTOMOSING THE INTERNAL MAMMARY ARTERY, THE VASCULAR SUTURE NEEDLE WAS TOO BLUNT AND COULD NOT PENETRATE THE VESSEL WALL. VASCULAR BLEEDING OF AROUND 1 TO 2 CC OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24105338 ↗
• MalfunctionAug 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CORONARY ARTERY BYPASS, WHILE SUTURING, THE CONNECTION OF THE NEEDLE AND THREAD OF TWO SUTURES BROKE SUCCESSIVELY. ANASTOMOSIS WAS REPEATED THREE TIMES WITH A SUTURE FROM ANOTHER LOT NUMBER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715819 ↗
• MalfunctionAug 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A CORONARY ARTERY BYPASS, WHILE SUTURING, THE CONNECTION OF THE NEEDLE AND THREAD OF TWO SUTURES BROKE SUCCESSIVELY. ANASTOMOSIS WAS REPEATED THREE TIMES WITH A SUTURE FROM ANOTHER LOT NUMBER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715700 ↗
• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE BYPASS SURGERY, WHEN ON VASCULAR ANASTOMOSIS, THE NEEDLE BROKE ON THE SWAGE/CENTRAL PART. IMAGING TEST WAS THEN PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 21968953 ↗
• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE BYPASS SURGERY, WHEN ON VASCULAR ANASTOMOSIS, THE NEEDLE BROKE ON THE SWAGE/CENTRAL PART. IMAGING TEST WAS THEN PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 21968889 ↗
• MalfunctionMar 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DIGESTIVE REPAIR, WHEN THE TWO SUTURES WERE REMOVED FROM THE PACKAGING, THE TWO NEEDLES OF THE THREADS BECAME LOOSE AND DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724259 ↗
• MalfunctionMar 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A DIGESTIVE REPAIR, WHEN THE TWO SUTURES WERE REMOVED FROM THE PACKAGING, THE TWO NEEDLES OF THE THREADS BECAME LOOSE AND DETACHED. A NEW SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724217 ↗
• MalfunctionFeb 26, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OFF-PUMP CORONARY ARTERY BYPASS GRAFTING, THE THREAD BROKE ON ITS OWN DURING THE CRITICAL STEP OF SUTURING AND KNOTTING, REQUIRING THE OPERATION TO BE RE-SUTURED, AFFECTING THE PROGRESS OF THE OPERATION. ANOTHER SUTURE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 21471151 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LIVER TRANSPLANT INVOLVING THE SUTURE, THE SUTURE BROKE TWICE WHILE SUTURING. THE BREAKAGE OCCURRED IN THE MIDDLE OF THE SUTURE. THE ISSUE WAS RESOLVED BY USING A NEW SUTURE FROM A DIFFERENT BATCH. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314563 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LIVER TRANSPLANT INVOLVING THE SUTURE, THE SUTURE BROKE TWICE WHILE SUTURING. THE BREAKAGE OCCURRED IN THE MIDDLE OF THE SUTURE. THE ISSUE WAS RESOLVED BY USING A NEW SUTURE FROM A DIFFERENT BATCH. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21314557 ↗
• MalfunctionSep 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING THE ANASTOMOSIS. THIS ISSUE OCCURRED ON SEVEN DEVICES. NO PIECES FALL IN THE PATIENT CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED FROM ANOTHER BATCH. THE PROCEDURE TIME WAS EXTENDED FOR AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305480 ↗
• MalfunctionSep 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING THE ANASTOMOSIS. THIS ISSUE OCCURRED ON SEVEN DEVICES. NO PIECES FALL IN THE PATIENT CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED FROM ANOTHER BATCH. THE PROCEDURE TIME WAS EXTENDED FOR AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305351 ↗
• MalfunctionSep 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING THE ANASTOMOSIS. THIS ISSUE OCCURRED ON SEVEN DEVICES. NO PIECES FALL IN THE PATIENT CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED FROM ANOTHER BATCH. THE PROCEDURE TIME WAS EXTENDED FOR AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305154 ↗
• MalfunctionSep 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING THE ANASTOMOSIS. THIS ISSUE OCCURRED ON SEVEN DEVICES. NO PIECES FALL IN THE PATIENT CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED FROM ANOTHER BATCH. THE PROCEDURE TIME WAS EXTENDED FOR AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305081 ↗
• MalfunctionSep 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING THE ANASTOMOSIS. THIS ISSUE OCCURRED ON SEVEN DEVICES. NO PIECES FALL IN THE PATIENT CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED FROM ANOTHER BATCH. THE PROCEDURE TIME WAS EXTENDED FOR AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305006 ↗
• MalfunctionSep 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING THE ANASTOMOSIS. THIS ISSUE OCCURRED ON SEVEN DEVICES. NO PIECES FALL IN THE PATIENT CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED FROM ANOTHER BATCH. THE PROCEDURE TIME WAS EXTENDED FOR AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304817 ↗
• MalfunctionSep 25, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE NEEDLE BROKE WHILE SUTURING THE ANASTOMOSIS. THIS ISSUE OCCURRED ON SEVEN DEVICES. NO PIECES FALL IN THE PATIENT CAVITY. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED FROM ANOTHER BATCH. THE PROCEDURE TIME WAS EXTENDED FOR AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20304793 ↗