SurgidacRecalls & reported problems across all models
Covidien LP · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Surgidac model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 199
- Deaths reported
- 0
- Injuries reported
- 50
- Recalls
- 1
We found 9 models of Surgidac by Covidien LP in the FDA's device registry (GUDID). Together they are named in 199 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2016 and Mar 17, 2026 — classified as 50 injuries, 149 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (105 reports).
1 FDA recall record name at least one of these models by its device 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. 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
Reports received per month, all models
Surgidac 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.
- Dec 2, 2022Open, 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-1177-2023 · Root cause: Packaging process control · Recall details · FDA record ↗
Most reported Surgidac problems
Device problems
- Detachment of Device or Device Component105
- Break76
- Human-Device Interface Problem69
- Detachment Of Device Component56
- Component or Accessory Incompatibility19
- Adverse Event Without Identified Device or Use Problem11
- Entrapment of Device6
- Unraveled Material5
Patient problems
- No Known Impact Or Consequence To Patient85
- No Clinical Signs, Symptoms or Conditions36
- Foreign Body In Patient29
- No Consequences Or Impact To Patient29
- No Code Available15
- Radiation Exposure, Unintended9
- Unintended Radiation Exposure7
- Device Embedded In Tissue or Plaque6
Surgidac models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Surgidac 173024Endoscopic tissue approximation device70 reports
- Surgidac 173023Endoscopic tissue approximation device55 reports
- Surgidac D-1764KSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE1 recall0 reports
- Surgidac 173021Endoscopic tissue approximation device27 reports
- Surgidac 173026Endoscopic tissue approximation device12 reports
- Surgidac 170043Endoscopic tissue approximation device11 reports
- Surgidac 170040Endoscopic tissue approximation device10 reports
- Surgidac 170044Endoscopic tissue approximation device9 reports
- Surgidac 170041Endoscopic tissue approximation device5 reports
Recent Surgidac adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 17, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE NEEDLE BECAME DETACHED FROM THE THREAD. THE NEEDLE WAS EMBEDDED IN THE PATIENT AND WAS UNABLE TO BE RETRIEVED.
Patient problems: Foreign Body In Patient
MAUDE report 24624264 ↗MalfunctionFeb 18, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377535 ↗InjuryFeb 17, 2026Break; Detachment of Device or Device Component; Human-Device Interface Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC INSERTION OF A MEDIPORT, AFTER TWO SUCCESSFUL DEVICE USES WHEN SUTURING THE SURROUNDING TISSUE OF THE CATHETHER TO THE ABDOMINAL WALL, THE DEVICE WAS RELOADED BY THE SCRUB NURSE AND HANDED OFF TO THE SURGEON. THE DEVICE WAS CYCLED, THEN THE SURGEON INSERTED IT IN THE CAVITY OF THE PATIENT, PLACED THE TISSUE BETWEEN THE JAWS OF THE INSTRUMENT, CLOSED THE JAWS AND CYCLED THE INSTRUMENT, HOWEVER THE NEEDLE DID NOT GO THROUGH THE TISSUE AND WAS LODGED IN THE ABDOMEN. ATTEMPTS TO PULL THE SUTURE OUT WITH THE NEEDLE IN THE PATIENT'S ABDOMEN WERE UNSUCCESSFUL AND THEN THE NEEDLE BROKE OFF THE SUTURE. THE NEEDLE WAS LEFT IN THE ABDOMEN.
Patient problems: Foreign Body In Patient
MAUDE report 24361610 ↗MalfunctionOct 23, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC ESOPHAGECTOMY, TOWARDS THE END OF THE PROCEDURE, THE RESIDENT ASSISTING WITH THE DEVICE PLACED THE NEEDLE THROUGH NORMAL TISSUE, AND AFTER PULLING THE NEEDLE THROUGH THE OTHER END, THE DEVICE WAS NOT FULLY CLOSED. THE RESIDENT THEN PULLED THE DEVICE TO EXTEND THE SUTURE WHILE IT WAS OPEN, RESULTING IN THE NEEDLE BREAKING IN HALF. THE BROKEN NEEDLE FELL INTO THE CAVITY OF THE PATIENT AND WAS RETRIEVED WITH A GRASPER. THE STAFF REMOVED THE NEEDLE AND SUTURING DEVICE FROM THE STERILE FIELD AND OPENED A NEW NEEDLE AND SUTURING DEVICE TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23367426 ↗InjuryAug 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE USING THE ENDOSTITCH INSTRUMENT, A NEEDLE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. THE SURGICAL TEAM WAS UNABLE TO LOCATE THE NEEDLE, SO IT WAS LEFT INSIDE THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 22841592 ↗MalfunctionJul 18, 2025Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR, WHILE SUTURING AND TYING THE KNOTS WITH THE ENDOSTITCH SUTURE, IT WAS FRAYING, AND THE SUTURE POPPED OFF THE NEEDLE WITH HARDLY ANY PRESSURE OR FORCE. THE SAME ISSUE OCCURRED ON A TOTAL OF 12 SUTURES FROM THE SAME BATCH AND ONE SUTURE FROM A DIFFERENT BATCH NUMBER. THE SURGEON OPENED MORE SUTURES FROM A DIFFERENT BATCH NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22542076 ↗MalfunctionJul 18, 2025Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR, WHILE SUTURING AND TYING THE KNOTS WITH THE ENDOSTITCH SUTURE, IT WAS FRAYING, AND THE SUTURE POPPED OFF THE NEEDLE WITH HARDLY ANY PRESSURE OR FORCE. THE SAME ISSUE OCCURRED ON A TOTAL OF 12 SUTURES FROM THE SAME BATCH AND ONE SUTURE FROM A DIFFERENT BATCH NUMBER. THE SURGEON OPENED MORE SUTURES FROM A DIFFERENT BATCH NUMBER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22542052 ↗MalfunctionJun 7, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, SPECIFICALLY DURING THE HIATAL HERNIA REPAIR, THE NEEDLE BROKE WHEN P ASSING THROUGH MUSCLE, AND HALF OF THE NEEDLE FELL INTO THE CAVITY OF THE PATIENT. THE BROKEN HALF OF THE NEEDLE WAS SUCCESSFULLY RETRIEVED WITH A WITH LAPAROSCOPIC HAND INSTRUMENT, AND A NEW SUTURE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22163380 ↗InjuryJun 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, THE NEEDLE BROKE OFF AND FELL INTO THE CAVITY OF THE PATIENT. IT WAS NOTED THAT PARTIAL PORTION OF THE NEEDLE WAS NOT RETRIEVED
Patient problems: Foreign Body In Patient
MAUDE report 22138192 ↗InjuryApr 3, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HIATAL HERNIA REPAIR USING THE INSTRUMENT, THE NEEDLE BROKE DURING SUTURING, AND HALF OF THE NEEDLE WAS LEFT IN THE PATIENT. THE SURGICAL TEAM OPENED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 21759801 ↗MalfunctionMar 13, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC DIAPHRAGMATIC PLICATION, DURING PLICATING THE DIAPHRAGM, THE NEEDLES OF THE TWO RELOADS BROKE AND JAMMED ON THE JAWS. THERE WAS DIFFICULTY ON UNLOADING AS WELL WITH THE FIRST RELOAD. THE TWO RELOADS WERE BOTH USED ON THE SAME HANDLE. A NEW INSTRUMENT AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21596176 ↗MalfunctionMar 13, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC DIAPHRAGMATIC PLICATION, DURING PLICATING THE DIAPHRAGM, THE NEEDLES OF THE TWO RELOADS BROKE AND JAMMED ON THE JAWS. THERE WAS DIFFICULTY ON UNLOADING AS WELL WITH THE FIRST RELOAD. THE TWO RELOADS WERE BOTH USED ON THE SAME HANDLE. A NEW INSTRUMENT AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21596158 ↗InjuryJan 2, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING THE CLOSING OF THE GASTROJEJUNAL ANASTOMOSIS, THE NEEDLE BROKE IN HALF, AND HALF OF THE NEEDLE WAS EMBEDDED INTO THE TISSUE AT THE GASTROJEJUNUM. THE SURGEON DID NOT IDENTIFY FROM THE INTRA-ABDOMINAL VIEW OR THE ENDOSCOPIC VIEW, SO THE DOCTOR JUST LEAVE THE NEEDLE IN PLACE INSTEAD OF TAKING DOWN THE WHOLE ANASTOMOSIS AND DIGGING IN THE TISSUE BLINDLY. BECAUSE OF THIS, THE PATIENT HAD A SMALL PORTION OF THE NEEDLE STILL INSIDE THE CAVITY.
Patient problems: Foreign Body In Patient
MAUDE report 21056729 ↗MalfunctionDec 3, 2024Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE ENDO STITCH INSTRUMENT, THERE WERE DIFFICULTIES ENCOUNTERED WITH THE DEVICE. THE FIRST INSTRUMENT WAS NOT WORKING AS IT SHOULD, IT WOULD NOT OPEN ONCE THE NEEDLE WAS LOADED. WHILE ON THE SECOND INSTRUMENT, THE NEEDLE WAS UNABLE TO BE REMOVED. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH ANOTHER ONE TO COMPLETE THE CASE. THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20833133 ↗MalfunctionSep 20, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE OF THE DEVICE BROKE IN TWO AND FELL INSIDE THE PATIENT. BOTH SIDES OF THE NEEDLE WAS ABLE TO BE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20271463 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page