SureFormRecalls & reported problems across all models

We found 16 models of SureForm by Intuitive Surgical, Inc. in the FDA's device registry (GUDID). Together they are named in 1,190 adverse event reports in the FDA's MAUDE database, received between Dec 5, 2018 and Sep 30, 2026 — classified as 5 deaths, 406 injuries, 779 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (258 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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

SureForm 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 11, 2026Open, Classified

   Reloads for curved-tipped stapler may potentially produce an incomplete staple line.

   Z-1855-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Oct 7, 2022Open, Classified

   Potential staple deployment failure and device fragment generation

   Z-0340-2023 · Root cause: Nonconforming Material/Component · names 4 of these models · Recall details · FDA record ↗

3. Mar 17, 2022Open, Classified

   As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitive s existing risk documentation.

   Z-0999-2022 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗

Most reported SureForm problems

SureForm models

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

• SureForm 480460

  System, surgical, computer controlled instrument
  1 recall1 death409 reports
• SureForm 480545

  Staple, implantable
  1 recall3 deaths141 reports
• SureForm 480445

  Staple, implantable
  1 recall115 reports
• SureForm 48360B

  STAPLE, IMPLANTABLE
  136 reports
• Sureform 48230M

  Staple, implantable
  2 recalls11 reports
• Sureform 488530

  Staple, implantable
  1 recall1 death34 reports
• Sureform 48230W

  System, surgical, computer controlled instrument
  1 recall34 reports
• SureForm 48360G

  STAPLE, IMPLANTABLE
  69 reports
• Sureform 48230B

  System, surgical, computer controlled instrument
  1 recall19 reports
• SureForm 48345G

  Staple, implantable
  58 reports
• SureForm 48360W

  STAPLE, IMPLANTABLE
  46 reports
• SureForm 48345W

  System, surgical, computer controlled instrument
  41 reports
• SureForm 48345T

  Staple, implantable
  29 reports
• SureForm 48360T

  STAPLE, IMPLANTABLE
  25 reports
• SureForm 48345B

  System, surgical, computer controlled instrument
  22 reports
• SureForm 48345M

  Staple, implantable
  1 report

Recent SureForm adverse event reports

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

• MalfunctionSep 30, 2026Break; Unintended Movement

  Patient problems: Insufficient Information

  MAUDE report 50953177 ↗
• InjurySep 29, 2026Failure to Form Staple; Firing Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 50941351 ↗
• MalfunctionSep 28, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926105 ↗
• MalfunctionSep 28, 2026Ejection Problem

  Patient problems: Insufficient Information

  MAUDE report 50925589 ↗
• MalfunctionSep 25, 2026Break; No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905856 ↗
• MalfunctionSep 24, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50891155 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50890791 ↗
• MalfunctionSep 24, 2026Difficult to Open or Close

  It was reported that during a da Vinci-assisted Low Anterior Resection surgical procedure, a SureForm 45 Stapler instrument would not dislodge from patient and got stuck on the Universal Surgical Manipulator (USM). The procedure was completed with no reported injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50887893 ↗
• MalfunctionSep 23, 2026Break; Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875357 ↗
• MalfunctionSep 23, 2026Material Fragmentation

  It was reported that during a da Vinci-assisted surgical procedure, the Sureform 45 Stapler was unable to open. The customer was unsure if firing had occurred. The surgeon engaged the enhanced force and the tissue was stapled and cut completely. The user completed the procedure using a backup stapler with no further issue reported. No fragment fell inside the patient. No known impact or patient consequence was reported.ISI followed up with the initial reporter and obtained the following additional information: The instrument was able to staple and cut normally. There was no stapling issue. This occurred while using a white reload. The customer was able to open the jaws successfully. There was no bleeding observed and no unplanned tissue removal. The customer used a new stapler to continue the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864019 ↗
• InjurySep 18, 2026Material Fragmentation; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50827193 ↗
• MalfunctionSep 3, 2026Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595219 ↗
• MalfunctionSep 1, 2026Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50536892 ↗
• InjuryAug 31, 2026Firing Problem

  It was reported that during a da Vinci-assisted pulmonary lobectomy surgical procedure, the White SureForm 45 Reload staple line bled after a misfire; the staple line was incomplete. The site reported being required to manually select the Reload color from the Surgeon Side Console before the fire. The SureForm 45 Curved-Tip Stapler was replaced with a backup stapler. After a successful firing sequence, no error messages were observed; the White staple line bled and required intervention. The surgeon reports the level of bleeding produced from the staple line was unexpected; the estimated blood loss was not provided. The bleeding was controlled intraoperatively; the procedure was completed robotically with a backup reload.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 50524123 ↗
• MalfunctionAug 27, 2026No Apparent Adverse Event

  The SureForm 60 Blue Reload accessory was an incidental return with no allegation made against this product. No known impact or patient consequence was reported.

  Patient problems: Insufficient Information

  MAUDE report 50486951 ↗

Other Intuitive Surgical, Inc. products

• EndoWrist62 models · 69,753 reports · 48 recalls
• daVinci Xi4 models · 11,477 reports · 3 recalls
• EndoWrist;daVinci Si35 models · 1,683 reports · 8 recalls
• daVinci 53 models · 1,608 reports · 5 recalls
• da Vinci Surgical System9 models · 1,459 reports · 5 recalls
• Ion6 models · 1,367 reports · 3 recalls
• EndoWrist SP20 models · 993 reports · 1 recall
• daVinci Si8 models · 681 reports · 1 recall