BeaconRecalls & reported problems across all models
Covidien LP · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Beacon model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15
- Deaths reported
- 1
- Injuries reported
- 12
- Recalls
- 2
We found 5 models of Beacon by Covidien LP in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between Jun 10, 2019 and Mar 13, 2025 — classified as 1 death, 12 injuries, 2 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
Reports received per month, all models
Beacon 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.
- Jun 26, 2020Open, Classified
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
Z-2769-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 26, 2020Open, Classified
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula was not retrieved during the procedure. Potential risks associated with a detached cannula include delay in treatment, biliary leak, pain and retained device fragments.
Z-2768-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Beacon problems
Device problems
- Adverse Event Without Identified Device or Use Problem8
- Break3
- Insufficient Device Problem Information3
- Detachment of Device or Device Component2
- Difficult to Advance2
- Premature Separation1
- Separation Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding4
- No Code Available3
- Pancreatitis3
- Device Embedded In Tissue or Plaque2
- Injury2
- Bradycardia1
- Inflammation1
- No Consequences Or Impact To Patient1
Beacon models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Beacon DSA-135-01Biopsy Needle1 recall4 reports
- Beacon DSA-090-01Biopsy needle1 recall2 reports
- Beacon DSN-22-01Biopsy needle1 death7 reports
- Beacon DSN-25-01Biopsy needle1 report
- Beacon N-22-05Biopsy needle1 report
Recent Beacon adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING THE PROCEDURE OF SOLID MASS TISSUE SAMPLE, BLEEDING OCCURRED. A CLIP WAS USED TO STOP THE BLEEDING.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21595478 ↗DeathJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THEY HAD A CASE OF SEVERE BLEEDING AND PANCREATITIS AFTER A FINE NEEDLE BIOPSY AND FINE NEEDLE ASPIRATION PROCEDURES FOR CYST ASPIRATION, CYST ASPIRATION WITH SOLID COMPONENTS, AND SOLID MASS TISSUE SAMPLE, AND ONE PATIENT DIED AS A RESULT OF THE COMPLICATION USING FINE NEEDLE ASPIRATION NEEDLE. PATIENT WAS ADMITTED THE DAY AFTER BEACON FNA PROCEDURE DUE TO FULMINANT ACUTE PANCREATITIS. PATIENT DIED THE FOLLOWING DAY AFTER ADMITTED, WITH MULTI-ORGAN FAILURE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis
MAUDE report 21152969 ↗InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT AFTER FINE NEEDLE BIOPSY (FNB) 22G 2 PASSES, PATIENT HAD BLEEDING WITH CLIPS AND ADRENALINE USED FOR MANAGEMENT. INTRALUMINAL BLEEDING, INTRA-PROCEDURAL HEMOSTASIS WITH 1:20,000 ADRENALINE SOLUTION 4ML AND 2 CLIPS. PATIENT FINAL DIAGNOSIS HEAD PANCREATIC SOLID-CYSTIC MIXED 3, 2CM LESION-MICROCYSTIC ADENOMA.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis
MAUDE report 21137984 ↗InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT AFTER FINE NEEDLE BIOPSY (FNB) AND FINE NEEDLE ASPIRATION (FNA) PROCEDURE, A PATIENT HAD A COMPLICATION OF PANCREATITIS AND SEVERE BLEEDING WHICH LED TO EXTENDED HOSPITALIZATION.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis
MAUDE report 21137869 ↗InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE PATIENT DEVELOPED PANCREATITIS AFTER HAVING THE MARKERS IMPLANTED. LAST PATIENT STATUS WAS UNKNOWN.
Patient problems: Inflammation
MAUDE report 16717901 ↗InjuryJul 13, 2020Difficult to Advance; Difficult to Advance
ACCORDING TO THE REPORTER, THE PHYSICIAN TRIED TO GAIN ACCESS TO THE PATIENT'S COMMON BILE DUCT DURING THE RENDEZVOUS PROCEDURE BUT THEY COULD NOT PASS THE GUIDE WIRE THROUGH THE STRICTURE AND IT KEPT GOING TOWARD THE HILUM. THE PATIENT HAD A DISTAL BILIARY OBSTRUCTION WITH A COMMON DUCT DIAMETER OF AROUND 12 MM. THEY TRIED TO PUT THE STYLET BACK INTO THE CANNULA TO MAKE THE HOOK STRAIGHT AGAIN BEFORE REMOVING IT BUT WAS UNABLE TO INSERT CANNULA TO THE END. THE CANNULA WOULD NOT GO BACK INTO THE DEVICE AND THEY COULD NOT REMOVE WITHOUT THE TIP BEING HOOKED. THE INCIDENT OCCURRED ON FIRST PASS. ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) WAS ATTEMPTED JUST PRIOR TO THE RENDEZVOUS ATTEMPT, BUT ERCP CANNULATION HAD FAILED. THE PHYSICIAN ALSO ATTEMPTED TO USE A 90 DEGREE ACCESS DEVICE, THE GUIDE WIRE INSERTED BUT IT AGAIN KEPT GOING INTO THE HILUM. THE GUIDE WIRE WAS REMOVED AND THE STYLET WAS RE-INSERTED PRIOR TO THE REMOVAL OF THE 90 DEGREE CATHETER. AT NO POINT DID THE GUIDE WIRE SUCCESSFULLY MAKE THE TURN AND PROCEED ANTEGRADE. THERE WAS NO IMMEDIATE COMPLICATIONS NOTED. A CT SCAN WAS PERFORMED THE FOLLOWING DAY AS PART OF PANCREATIC CA STAGING, AND BILIARY LEAK WAS IDENT
Patient problems: No Code Available
MAUDE report 10263884 ↗InjuryJul 10, 2020Difficult to Advance; Difficult to Advance
ACCORDING TO THE REPORTER, THE PHYSICIAN TRIED TO GAIN ACCESS TO THE PATIENT'S COMMON BILE DUCT DURING THE RENDEZVOUS PROCEDURE BUT THEY COULD NOT PASS THE GUIDE WIRE THROUGH THE STRICTURE AND IT KEPT GOING TOWARD THE HILUM. THE PATIENT HAD A DISTAL BILIARY OBSTRUCTION WITH A COMMON DUCT DIAMETER OF AROUND 12 MM. THEY TRIED TO PUT THE STYLET BACK INTO THE CANNULA TO MAKE THE HOOK STRAIGHT AGAIN BEFORE REMOVING IT BUT WAS UNABLE TO INSERT CANNULA TO THE END. THE CANNULA WOULD NOT GO BACK INTO THE DEVICE AND THEY COULD NOT REMOVE WITHOUT THE TIP BEING HOOKED. THE INCIDENT OCCURRED ON FIRST PASS. ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) WAS ATTEMPTED JUST PRIOR TO THE RENDEZVOUS ATTEMPT, BUT ERCP CANNULATION HAD FAILED. THE PHYSICIAN ALSO ATTEMPTED TO USE A 90 DEGREE ACCESS DEVICE, THE GUIDE WIRE INSERTED BUT IT AGAIN KEPT GOING INTO THE HILUM. THE GUIDE WIRE WAS REMOVED AND THE STYLET WAS RE-INSERTED PRIOR TO THE REMOVAL OF THE 90 DEGREE CATHETER. AT NO POINT DID THE GUIDE WIRE SUCCESSFULLY MAKE THE TURN AND PROCEED ANTEGRADE. THERE WAS NO IMMEDIATE COMPLICATIONS NOTED. A CT SCAN WAS PERFORMED THE FOLLOWING DAY AS PART OF PANCREATIC CA STAGING, AND BILIARY LEAK WAS IDENT
Patient problems: No Code Available
MAUDE report 10260212 ↗InjuryJun 15, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NEEDLE BROKE OFF INTO THE PATIENT'S STOMACH. THE PATIENT HAD A MALIGNANT PANCREATIC MASS INVOLVING THE PROXIMAL DUODENUM AND COMPRESSED THE MID COMMON BILE DUCT (CBD) AND PORTAL VEIN. SINCE THE DUODENUM COULD NOT BE REACHED WITH THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND THEY USED RENDEZVOUS AND PLANNED ON COMPLETING PROCEDURE WITH AN ESOPHAGOGASTRODUODENOSCOPY. THEY USED A DISTAL ANTRUM AS ACCESS POINT WHICH GIVES A SIMILAR VIEW AS THE DUODENAL BULB. THEY FIRST USED THE 90 NEEDLE WHICH WORKED WELL AND THE WIRE COULD NOT BE ADVANCED INTO THE COMMON BILE DUCT AND KEPT GOING INTO THE INTRAHEPATIC'S AND GIVEN FINDINGS OF 135 WOULD GAVE THEM A BETTER ANGLE. THE 90 WAS REMOVED UNEVENTFULLY AND THEN USED THE 135. INITIALLY THE WIRE WENT INTO THE INTRAHEPATIC'S. THEY THEN ROTATED IT 180 DEGREES OR SO WITHOUT ANY ISSUES AND WIRE WENT INTO THE COMMON BILE DUCT AS STANDARD (AND WIRE WAS PASSED THROUGH AMPULLA). THE PHYSICIAN PULLED THE NEEDLE INTO THE SCOPE AND IT DID NOT LEAVE ITS POSITION. THERE WAS NO RESISTANCE OR ABNORMAL SOUNDS HEARD OR FELT. IT WAS NOTED THAT THE NEEDLE WAS BROKEN AS THEY COULD STILL SEE IT ON THE DEVICE AND AFTER WHOL
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 10153701 ↗InjuryJun 8, 2020Premature Separation; Premature Separation
ACCORDING TO THE REPORTER, THE TIP BROKE OFF IN THE DUODENUM. ABOUT 3 ATTEMPTS TO ACCESS THE DUCT WERE MADE. AFTER FIRST ATTEMPT, STYLET WAS WITHDRAWN, BUT THERE WAS NO CLEAR "HOOK" OF THE CANNULA APPRECIATED VISUALLY. THE STYLET WAS REINSERTED. THE NEEDLE WAS REPOSITIONED ABOUT 1 OR 2 MORE TIMES BUT AT NO POINT WAS THE HOOK OF THE CANNULA IDENTIFIED VISUALLY. ON ABOUT THE THIRD ATTEMPT, THE PHYSICIAN ZOOMED IN ON FLUORO AND NOTICED THAT THE STYLET WAS EXTENDING ROUGHLY 1CM BEYOND THE CANNULA. THE PHYSICIAN NOTICED THAT THE TIP MAY HAVE BROKEN OFF AND REMOVED THE DEVICE. ANOTHER DEVICE WAS USED WITH NO ISSUE AND THE GUIDEWIRE WAS PLACED ANTEGRADE INTO THE DUODENUM. BROKEN PORTION OF THE CANNULA WAS FOUND IN THE DUODENUM PRIOR TO COMPLETION OF THE RENDEZVOUS AND IT WAS RETRIEVED. THERE WERE NO FOREIGN MATERIALS THAT REMAINED INSIDE THE PATIENT'S BODY. NO TRAUMA WAS NOTED TO THE GUIDEWIRE, BUT THE GUIDEWIRE TIP APPEARED TO HAVE GOTTEN STUCK SUPERFICIALLY IN THE WALL OF THE DUODENUM AFTER PASSING THROUGH THE AMPULLA. THE STRICTURE WAS DILATE D, AND A STENT WAS PLACED. THE PATIENT TOLERATED THE PROCEDURE, AND NO HEALTH COMPLICATIONS WERE NOTED AS A RESULT OF THE DEVICE BREAK. THE PATIE
Patient problems: Injury
MAUDE report 10128652 ↗MalfunctionApr 9, 2020Separation Problem; Separation Problem
ACCORDING TO THE REPORTER, THE DEVICE SNAPPED IN HALF DURING THE PROCEDURE. THE HANDLE IS BROKEN SEEMED TO HAVE OCCURRED ON/AROUND THE TIME OF THE FIRST PASS ATTEMPTING TO ENTER THE BILE DUCT. AFTER IT BROKE, IT WAS DIFFICULT TO REMOVE IT FROM THE SCOPE AND IT SEEMED THAT A WRENCH WAS USED. THE CUSTOMER HAD TO CHANGE OUT THE SCOPE AND SWITCH TO A DIFFERENT MODALITY. IT WAS VERIFIED BY THE SALES REPRESENTATIVE THAT IT WAS A BROKEN HANDLE AND NOT A BROKEN CANNULA TIP. THERE WAS NO PATIENT AND USER HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9942623 ↗InjuryApr 1, 2020Break; Detachment of Device or Device Component; Insufficient Device Problem Information; Break; Detachment of Device or Device Component; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE DISTAL PORTION OF THE CANNULA BROKE OFF AND REMAINED IN PATIENT. THE PROCEDURE WAS ATTEMPTED WITH A 135 DEGREE CATHETER USING A DUCT THAT HAD AN ESTIMATED SIZE OF ABOUT 12-14 MM AND UEUS SCOPE. THE NEEDLE TIP WENT IN AND THERE WERE SOME REDUCED VISIBILITY AFTER THE STYLET WAS REMOVED WHICH THEY THOUGHT IT WAS RELATIVELY NORMAL OR EXPECTED. THE CONTRAST WAS INJECTED AND THERE WERE SOME LEAKAGE OF CONTRAST OUTSIDE THE DUCT WHICH WAS LIKELY FROM THE TOP FENESTRATION. THE STYLET WAS PUSHED BACK IN FOR POSITION ADJUSTMENT BUT THERE WAS RESISTANCE FROM ABOUT 10 CM BEFORE IT WOULD HAVE BEEN HUBBED. THE ATTEMPTED ADJUSTMENT SEEMED UNSUCCESSFUL SO THE PHYSICIAN DECIDED TO PULL THE CANNULA BACK INTO THE SCOPE. AFTER THAT, THE STYLET WAS SUCCESSFULLY REINSERTED. THE DEVICE WAS REMOVED FROM THE SCOPE AND THEY NOTICED AN ABNORMAL APPEARANCE OF THE DISTAL TIP. APPROXIMATELY 90-95% OF THE FENESTRATED END SHEERED OFF INTO THE DUCT WITH A SOMEHOW HORSESHOE SHAPE. THE CUSTOMER STATED THAT MOTIONS WERE CAREFUL WITH THE SCOPE AND THERE WAS NOT MUCH ROTATION OF THE CANNULA DURING THE PROCEDURE, JUST A MM OR TWO. THE PHYSICIAN WAS UNCERTAIN AS TO WHAT POINT OF THE PROCEDUR
Patient problems: Device Embedded In Tissue or Plaque; Injury; Pain
MAUDE report 9909014 ↗InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THIS WAS STUDY REGARDING A COMPARISON BETWEEN 2 METHODS OF USING THE ASPIRATION NEEDLE. THERE WERE FINDINGS OF COMPLICATIONS ON BOTH METHODS. POST STUDY REVEALED THAT THERE WERE 5 COMPLICATIONS IN THE CYTOPATHOLOGIST -GUIDED ARM WHICH INCLUDED THREE ACUTE PANCREATITIS WHEREIN ONE PATIENT HAD UNDERGONE AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY AT THE SAME TIME OBTAINING ADEQUATE ASPIRATE OF SOLID MASS (PANCREATIC) USING EUS. THERE WAS ONE PATIENT THAT FELL DURING THE RECOVERY PERIOD, BUT WITHOUT ASSOCIATED INJURIES. THE LAST PATIENT HAD A BROKEN NEEDLE REQUIRING REMOVAL OF THE ECHOENDOSCOPE. BASED FROM THE SEVEN-PASSES THERE WERE THREE COMPLICATIONS WHICH INCLUDED TO ONE PATIENT EXPERIENCING AN INTRAPROCEDURE BRADYCARDIA THAT WAS RESPONDED WITH ATROPINE. ANOTHER PATIENT EXPERIENCED A RESPIRATORY DISTRESS LEADING TO THE PROCEDURE BEING ABORTED. THE LAST PATIENT DEVELOPED ABDOMINAL PAIN AND FEVER (NORMAL LABORATORY STUDIES AND ABDOMINAL COMPUTED TOMOGRAPHY) THAT EVENTUALLY RESOLVED SPONTANEOUSLY.
Patient problems: Sedation
MAUDE report 8701877 ↗MalfunctionJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THIS WAS STUDY REGARDING A COMPARISON BETWEEN 2 METHODS OF USING THE ASPIRATION NEEDLE. THERE WERE FINDINGS OF COMPLICATIONS ON BOTH METHODS. POST STUDY REVEALED THAT THERE WERE 5 COMPLICATIONS IN THE CYTOPATHOLOGIST -GUIDED ARM WHICH INCLUDED THREE ACUTE PANCREATITIS WHEREIN ONE PATIENT HAD UNDERGONE AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY AT THE SAME TIME OBTAINING ADEQUATE ASPIRATE OF SOLID MASS (PANCREATIC) USING EUS. THERE WAS ONE PATIENT THAT FELL DURING THE RECOVERY PERIOD, BUT WITHOUT ASSOCIATED INJURIES. THE LAST PATIENT HAD A BROKEN NEEDLE REQUIRING REMOVAL OF THE ECHOENDOSCOPE. BASED FROM THE SEVEN-PASSES THERE WERE THREE COMPLICATIONS WHICH INCLUDED TO ONE PATIENT EXPERIENCING AN INTRAPROCEDURE BRADYCARDIA THAT WAS RESPONDED WITH ATROPINE. ANOTHER PATIENT EXPERIENCED A RESPIRATORY DISTRESS LEADING TO THE PROCEDURE BEING ABORTED. THE LAST PATIENT DEVELOPED ABDOMINAL PAIN AND FEVER (NORMAL LABORATORY STUDIES AND ABDOMINAL COMPUTED TOMOGRAPHY) THAT EVENTUALLY RESOLVED SPONTANEOUSLY.
Patient problems: Respiratory Distress
MAUDE report 8685024 ↗InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THIS WAS STUDY REGARDING A COMPARISON BETWEEN 2 METHODS OF USING THE ASPIRATION NEEDLE. THERE WERE FINDINGS OF COMPLICATIONS ON BOTH METHODS. POST STUDY REVEALED THAT THERE WERE 5 COMPLICATIONS IN THE CYTOPATHOLOGIST -GUIDED ARM WHICH INCLUDED THREE ACUTE PANCREATITIS WHEREIN ONE PATIENT HAD UNDERGONE AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY AT THE SAME TIME OBTAINING ADEQUATE ASPIRATE OF SOLID MASS (PANCREATIC) USING EUS. THERE WAS ONE PATIENT THAT FELL DURING THE RECOVERY PERIOD, BUT WITHOUT ASSOCIATED INJURIES. THE LAST PATIENT HAD A BROKEN NEEDLE REQUIRING REMOVAL OF THE ECHOENDOSCOPE. BASED FROM THE SEVEN-PASSES THERE WERE THREE COMPLICATIONS WHICH INCLUDED TO ONE PATIENT EXPERIENCING AN INTRAPROCEDURE BRADYCARDIA THAT WAS RESPONDED WITH ATROPINE. ANOTHER PATIENT EXPERIENCED A RESPIRATORY DISTRESS LEADING TO THE PROCEDURE BEING ABORTED. THE LAST PATIENT DEVELOPED ABDOMINAL PAIN AND FEVER (NORMAL LABORATORY STUDIES AND ABDOMINAL COMPUTED TOMOGRAPHY) THAT EVENTUALLY RESOLVED SPONTANEOUSLY.
Patient problems: Bradycardia
MAUDE report 8685016 ↗InjuryJun 10, 2019Break; Break
ACCORDING TO THE REPORTER, THIS WAS STUDY REGARDING A COMPARISON BETWEEN 2 METHODS OF USING THE ASPIRATION NEEDLE. THERE WERE FINDINGS OF COMPLICATIONS ON BOTH METHODS. POST STUDY REVEALED THAT THERE WERE 5 COMPLICATIONS IN THE CYTOPATHOLOGIST -GUIDED ARM WHICH INCLUDED THREE ACUTE PANCREATITIS WHEREIN ONE PATIENT HAD UNDERGONE AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY AT THE SAME TIME OBTAINING ADEQUATE ASPIRATE OF SOLID MASS (PANCREATIC) USING EUS. THERE WAS ONE PATIENT THAT FELL DURING THE RECOVERY PERIOD, BUT WITHOUT ASSOCIATED INJURIES. THE LAST PATIENT HAD A BROKEN NEEDLE REQUIRING REMOVAL OF THE ECHOENDOSCOPE. BASED FROM THE SEVEN-PASSES THERE WERE THREE COMPLICATIONS WHICH INCLUDED TO ONE PATIENT EXPERIENCING AN INTRAPROCEDURE BRADYCARDIA THAT WAS RESPONDED WITH ATROPINE. ANOTHER PATIENT EXPERIENCED A RESPIRATORY DISTRESS LEADING TO THE PROCEDURE BEING ABORTED. THE LAST PATIENT DEVELOPED ABDOMINAL PAIN AND FEVER (NORMAL LABORATORY STUDIES AND ABDOMINAL COMPUTED TOMOGRAPHY) THAT EVENTUALLY RESOLVED SPONTANEOUSLY.
Patient problems: No Code Available
MAUDE report 8684991 ↗
Other Covidien LP products
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- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
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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.
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