Cook TPN G07902Recalls & reported problems
Cook Incorporated · Cook TPN, Double Lumen Catheter Set With 8Fr Peel-Away, Introducer Set · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Cook TPN double-lumen catheter set is used to provide short-term intravenous treatment. The 25 reports mostly describe leaks, loose or separating parts, twisting, and breaks in the catheter, with one report mentioning a bacterial infection. They include 11 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00827002079021), received between Feb 13, 2016 and Mar 9, 2020 — classified as 11 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (8 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Leak/Splash8
- Fitting Problem6
- Material Separation3
- Bent2
- Break2
- Material Rupture2
- Uncoiled2
- Detachment Of Device Component1
Patient problems
- No Code Available11
- No Consequences Or Impact To Patient7
- No Known Impact Or Consequence To Patient6
- Bacterial Infection1
- Lymphoma1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2020Fitting Problem; Fitting Problem
IT WAS REPORTED THAT BOTH LUMENS OF A REDO DOUBLE LUMEN TPN CATHETER ARE ABLE TO BE ROTATED FREELY. CONSEQUENTLY, THE DEVICE WAS REMOVED FROM THE PATIENT. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE DEVICE, PATIENT, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9806541 ↗MalfunctionFeb 27, 2020Fitting Problem; Fitting Problem
NO ADDITIONAL PATIENT/EVENT INFORMATION HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9763198 ↗MalfunctionFeb 26, 2020Material Separation; Material Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9757837 ↗InjuryFeb 24, 2020Material Separation; Material Separation
IT WAS REPORTED THAT THE BLUE AND YELLOW LUMEN SHEATHS OF A REDO DOUBLE LUMEN TPN CATHETER SET BECAME LOOSE. THE YELLOW LUMEN SHEATH BECAME LOOSE ENOUGH TO BE SLID UP AND DOWN THE LINE. CONSEQUENTLY, THE LINE BROKE, WHICH ALLOWED BLOOD TO LEAK OUT OF THE AREA. THE PATIENT DEVELOPED A POSITIVE BLOOD CULTURE (COAGULASE NEGATIVE STAPHYLOCOCCUS) DUE TO THIS OCCURRENCE. THE BLUE SHEATH COULD ALSO BE MOVED, BUT DID NOT SLIDE UP AND DOWN. ADDITIONAL INFORMATION REGARDING THE EVENT, PATIENT, AND DEVICE HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Bacterial Infection; No Code Available
MAUDE report 9746294 ↗MalfunctionFeb 24, 2020Fitting Problem; Fitting Problem
IT WAS REPORTED THAT THE "CLEAR COVERING CLOSE TO THE CAP" OF A REDO DOUBLE LUMEN TPN CATHETER WAS "MOVING AND EXPOSING THE SHEATH BELOW, CAUSING SHEARING & FRICTION ON THE LINE". THE HUB OF THE TPN CATHETER WAS "TWISTING INSIDE THE SILICONE SLEEVE AT THE END OF THE EXTENSION TUBING", WHICH HAS LEAD TO FRICTION AND SHEARING OF THE DEVICE. THE CUSTOMER PROVIDED PICTURES AND A VIDEO OF THE REPORTED MALFUNCTION, SHOWING THE HUB BEING PARTIALLY PULLED OUT OF THE SILICONE SHEATH. THE PATIENT IS PEDIATRIC AND IS CURRENTLY UNDERGOING TREATMENT AT THE HOSPITAL. THEY ARE HIGHLY ACTIVE AND GENERALLY IMMUNOCOMPROMISED. THE PATIENT HAS NOT HAD THEIR LINE REMOVED BUT IS BEING WATCHED CLOSELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING DEVICE AND EVENT DETAILS BUT IS CURRENTLY UNAVAILABLE. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INSTANCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9745298 ↗MalfunctionFeb 24, 2020Fitting Problem; Fitting Problem
IT WAS REPORTED THAT THE "CLEAR COVERING CLOSE TO THE CAP" OF A REDO DOUBLE LUMEN TPN CATHETER WAS "MOVING AND EXPOSING THE SHEATH BELOW, CAUSING SHEARING & FRICTION ON THE LINE". THE HUB OF THE TPN CATHETER WAS "TWISTING INSIDE THE SILICONE SLEEVE AT THE END OF THE EXTENSION TUBING", WHICH HAS LEAD TO FRICTION AND SHEARING OF THE DEVICE. THE CUSTOMER PROVIDED PICTURES AND A VIDEO OF THE REPORTED MALFUNCTION, SHOWING THE HUB BEING PARTIALLY PULLED OUT OF THE SILICONE SHEATH. THE PATIENT IS PEDIATRIC AND IS CURRENTLY UNDERGOING TREATMENT AT THE HOSPITAL. THEY ARE HIGHLY ACTIVE AND GENERALLY IMMUNOCOMPROMISED. THE PATIENT HAS NOT HAD THEIR LINE REMOVED BUT IS BEING WATCHED CLOSELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING DEVICE AND EVENT DETAILS BUT IS CURRENTLY UNAVAILABLE. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INSTANCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9745168 ↗MalfunctionFeb 24, 2020Fitting Problem; Fitting Problem
IT WAS REPORTED THAT THE "CLEAR COVERING CLOSE TO THE CAP" OF A REDO DOUBLE LUMEN TPN CATHETER WAS "MOVING AND EXPOSING THE SHEATH BELOW, CAUSING SHEARING & FRICTION ON THE LINE". THE HUB OF THE TPN CATHETER WAS "TWISTING INSIDE THE SILICONE SLEEVE AT THE END OF THE EXTENSION TUBING", WHICH HAS LEAD TO FRICTION AND SHEARING OF THE DEVICE. THE CUSTOMER PROVIDED PICTURES AND A VIDEO OF THE REPORTED MALFUNCTION, SHOWING THE HUB BEING PARTIALLY PULLED OUT OF THE SILICONE SHEATH. THE PATIENT IS PEDIATRIC AND IS CURRENTLY UNDERGOING TREATMENT AT THE HOSPITAL. THEY ARE HIGHLY ACTIVE AND GENERALLY IMMUNOCOMPROMISED. THE PATIENT HAS NOT HAD THEIR LINE REMOVED BUT IS BEING WATCHED CLOSELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING DEVICE AND EVENT DETAILS BUT IS CURRENTLY UNAVAILABLE. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INSTANCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9745012 ↗MalfunctionFeb 24, 2020Fitting Problem; Fitting Problem
IT WAS REPORTED THAT A REDO DOUBLE LUMEN TPN CATHETER HAD BROKEN AND "THE SILICONE PART OF THE EXTENSION TUBING ACCESS WAS LOOSE". THE HUB OF THE TPN CATHETER WAS ABLE TO TWIST INSIDE THE SILICONE SHEATH. THE SHEARING AND TWISTING OF THE HUB INSIDE THE SHEATH CAUSED HOLES IN THE DEVICE. THIS DEVICE HAD PREVIOUSLY BEEN REPAIRED WITH A COOK TPN REPAIR KIT. THE CATHETER WAS REMOVED FROM THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING EVENT DETAILS BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9744630 ↗InjuryJan 2, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT ON (B)(6) 2018, A REDO DOUBLE LUMEN TPN CATHETER SET WAS IMPLANTED IN A (B)(6) YEAR OLD MALE PATIENT BUT AFTER A FEW HOURS WAS REMOVED DUE TO THE RUPTURE OF ONE LUMEN OF THE CATHETER. ANOTHER REDO DOUBLE LUMEN TPN CATHETER WAS IMPLANTED ON (B)(6) 2018. THE PATIENT REQUIRED ADDITIONAL ANESTHESIA FOR THE SECOND DEVICE IMPLANTATION. THIS REPORT IS RELATED TO MDR 1820334-2019-00017 AS THEY INVOLVE THE SAME PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH REGARDS TO THE DEVICE, EVENT, AND PATIENT DETAILS BUT HAVE NOT BEEN PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: No Code Available
MAUDE report 8209056 ↗MalfunctionJan 2, 2019Material Rupture; Material Rupture
IT WAS REPORTED THAT ON (B)(6) 2018, THERE WAS SPONTANEOUS RUPTURE OF ONE OF THE LUMENS IN A REDO DOUBLE LUMEN TPN CATHETER SET THAT HAD BEEN IMPLANTED IN A (B)(6) MALE PATIENT. THE DEVICE WAS INITIALLY IMPLANTED ON (B)(6) 2018 TO REPLACE A SIMILAR DEVICE THAT ALSO HAD A RUPTURED LUMEN. THIS EVENT IS REPORTED IN MDR 1820334-2019-00016. A REPAIR KIT WAS USED TO REPAIR THE DEVICE AND THE REDO DOUBLE LUMEN TPN CATHETER STAYED IN PLACE IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED WITH REGARDS TO THE DEVICE, EVENT, AND PATIENT DETAILS BUT HAVE NOT BEEN PROVIDED AT THE TIME OF THIS REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8209040 ↗InjuryJun 28, 2018Fracture; Fracture
IT WAS REPORTED A REDO DOUBLE LUMEN TPN CATHETER SET FRACTURED APPROXIMATELY 2-3 CM BELOW THE HUB. FOLLOWING THE CHAMBER-POT IN TUBING, THE FLOW HALTED. THE LINE WAS CLAMPED QUICKLY TO ENSURE THE INFLUX OF THERAPY WOULD DISCONTINUE. THE DEVICE WAS REMOVED. THE DEVICE HAD BEEN IN PLACE FOR 36 DAYS IN THE RIGHT SUBCLAVICAL VEIN AND DELIVERED 5 THERAPIES WITH AN INFUSION SPEED OF 60 ML/HR. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: Lymphoma
MAUDE report 7644935 ↗MalfunctionNov 14, 2017Partial Blockage; Break; Partial Blockage; Break
THE INTERNATIONAL CUSTOMER REPORTED THAT THE PEDIATRIC PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2017 WITH A BROKEN REDO DOUBLE LUMEN TPN CATHETER. THE CATHETER WAS INTENDED FOR LONG TERM TUNNELED BROVIAC USE AND HAD BEEN PLACED ON (B)(6) 2017. THE BREAK REPORTEDLY OCCURRED AT THE POINT OF BIFURCATION BETWEEN TWO SEPARATE LUMENS. ON INSPECTION, IT WAS OBSERVED THAT THE SUTURES WERE NOT PULLED, THE DRESSING WAS INTACT, AND THE END OF THE LINE WAS STRAIGHT CLEAN CUT. THE DOUBLE LUMEN SECTION WHICH HAD COME OFF OF THE CATHETER HAD ALREADY BEEN DISCARDED BY THE PATIENT'S CAREGIVER. THE LINE WAS REPAIRED USING A REPAIR KIT. THE LUMENS REPORTEDLY DID NOT FLUSH EASILY THEREAFTER, SO 1 MG CATHFLO WAS INSTILLED IN EACH LUMEN OVERNIGHT. THE PATIENT RETURNED THE FOLLOWING MORNING FOR BLOOD WORK AND A FOLLOW UP. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7031573 ↗MalfunctionAug 9, 2017Leak/Splash; Migration or Expulsion of Device
IT WAS REPORTED THERE IS A LEAKAGE ON THE BLUE "LEG" OF THE CATHETER. PER THE CUSTOMER, "THE CHILD WAS GOING INTO SURGERY AND THEY USED THE TPN CATHETER TO GIVE SEDATION, BUT THEY COULD SEE THAT IT WAS LEAKING AT THE BLUE LUMEN. WHEN CHILD RETURNED TO THE WARD THEY REPAIRED THE TPN LINE. " A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THEY HAD TO PLACE A PERIPHERAL VEIN ACCESS SITE TO BE ABLE TO SEDATE THE CHILD. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE
Patient problems: No Code Available
MAUDE report 6776266 ↗MalfunctionAug 8, 2017Detachment Of Device Component
THE COMPLAINANT ALLEGED THAT THE TIP ON THE WIRE GUIDE HAD FALLEN OFF. THIS PRODUCT ISSUE WAS RECOGNIZED UPON OPENING THE PACKAGE SO THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6773889 ↗MalfunctionAug 7, 2017Bent; Uncoiled
THE CUSTOMER REPORTED THAT THE DEVICE'S WIRE WAS FOUND TO BE BENT, AND PHOTOS SHOWED THE TIP OF THE WIRE TO BE SLIGHTLY UNCOILED. THE DEVICE DID NOT MAKE PATIENT CONTACT, AND THERE WERE NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6770273 ↗MalfunctionAug 7, 2017Bent; Uncoiled
THE CUSTOMER REPORTED THAT THE DEVICE WAS RECEIVED WITH A BENT WIRE, AND PHOTOS SHOWED THAT THE TIP WAS PARTIALLY UNCOILED. THIS WAS FOUND BEFORE PATIENT CONTACT, SO THERE WERE NO INJURIES OR ADDITIONAL MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6770220 ↗InjuryApr 19, 2017Break; Break
INTERNATIONAL CUSTOMER REPORTED THAT A REDO DOUBLE LUMEN TPN CATHETER SET USED FOR TOTAL PARENTERAL NUTRITION (TPN) BROKE AT AN UNSPECIFIED TIME FOLLOWING IMPLANTATION. THE DEVICE WAS INITIALLY IMPLANTED FOLLOWING A PREVIOUS CATHETER BREAKAGE. THE CONDITIONS AND HANDLING CIRCUMSTANCES LEADING UP TO THE EVENT ARE NOT KNOWN. THE DEVICE WAS COMPLETELY EXPLANTED AND REPLACED. NO FURTHER EVENT OR PATIENT INFORMATION WAS PROVIDED. THIS IS ONE OF TWO REPORTS BEING SUBMITTED AS TWO DEVICES REPORTEDLY BROKE. REFERENCE MDR NUMBERS 1820334-2017-00707 AND 1820334-2017-00710. THE SAME PATIENT IS ASSOCIATED WITH BOTH REPORTS.
Patient problems: No Code Available
MAUDE report 6504782 ↗InjuryDec 12, 2016Leak/Splash; Leak/Splash
IT WAS REPORTED A DOUBLE LUMEN CATHETER, IMPLANTED ON (B)(6) 2016 FOR TOTAL PARENTERAL NUTRITION (TPN), WAS LEAKING AND WAS REPLACED WITH A NEW ONE ON (B)(6) 2016. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 6165743 ↗InjuryDec 1, 2016Material Separation; Material Separation
IT WAS REPORTED WHILE INSERTING A CATHETER INTO A (B)(6) YEAR OLD PATIENT, THE CUFF WAS BROKEN AND IS REPLACED WITH A NEW DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE: NEW CATHETER PLACEMENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 6139031 ↗MalfunctionOct 27, 2016Leak/Splash; Leak/Splash
A (B)(6) MALE PATIENT WAS HAVING AN UNKNOWN PROCEDURE WHEN IT WAS DISCOVERED THAT THE CATHETER HAD A HOLE AND WAS LEAKING. IT WAS REMOVED AND REPLACED WITH A NEW DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6061798 ↗InjuryOct 25, 2016Leak/Splash; Leak/Splash
IT WAS REPORTED A CATHETER PLACED ON (B)(6) 2016 IN A (B)(6) MALE PATIENT HAD A HOLE AT THE CONNECTION OF THE CATHETER HUB RESULTING IN LEAKAGE. THE CATHETER WAS REMOVED AND A REPLACEMENT TOTAL PARENTERAL NUTRITION CATHETER WAS PLACED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE
Patient problems: No Code Available
MAUDE report 6053465 ↗InjuryOct 25, 2016Leak/Splash; Leak/Splash
IT WAS REPORTED A CATHETER PLACED ON (B)(6) 2016 IN A (B)(6) FEMALE PATIENT HAD A HOLE AT THE CONNECTION OF THE CATHETER HUB RESULTING IN LEAKAGE. THE CATHETER WAS REMOVED AND A REPLACEMENT TOTAL PARENTERAL NUTRITION CATHETER WAS PLACED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS
Patient problems: No Code Available
MAUDE report 6053434 ↗InjuryOct 25, 2016Leak/Splash; Leak/Splash
IT WAS REPORTED A CATHETER PLACED ON (B)(6) 2016 IN A (B)(6) MALE PATIENT HAD A HOLE AT THE CONNECTION OF THE CATHETER HUB RESULTING IN LEAKAGE. THE CATHETER WAS REMOVED AND A REPLACEMENT TOTAL PARENTERAL NUTRITION CATHETER WAS PLACED . ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE
Patient problems: No Code Available
MAUDE report 6053430 ↗InjuryMar 31, 2016Leak/Splash; Leak/Splash
WHILE REPAIRING THE LINE, WHEN THE RN WAS GIVING MEDICINE, SHE UNCLAMPED THE BLUE LEG TO FLUSH AND A STREAM OF WATER CAME OUT THE SIDE OF THE CATHETER. THE PATIENT DID REQUIRE AN ADDITIONAL LINE PLACEMENT PROCEDURE DUE TO THIS OCCURRENCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 5537943 ↗InjuryFeb 13, 2016Leak/Splash; Leak/Splash
PER USER FACILITY MEDWATCH REPORT RECEIVED 28 JANUARY 2016: PATIENT'S DOUBLE LUMEN BROVIAC LINE LOCATED ON HIS LEFT CHEST WALL, WHEN FLUSHED, (TO PREPARE ADMINISTRATION OF CHEMOTHERAPY) BROKE. FLUID BEGAN LEAKING ABOVE THE BIFURCATION POINT WHEN FLUSHED. THE LINE WAS NOT LEAKING WHILE IV FLUIDS WERE INFUSING MOMENTS PRIOR. LINE WAS NOT FLUSHED WITH EXCESSIVE FORCE OR PULLED TO CREATE A WEAKENED SPOT. THE LINE WAS IMMEDIATELY HELD CLOSED, STAT LOCKS AND STERILE GAUZE APPLIED OVER THE HOLE AND THE LINE HELD CLOSED WITH THE STAT LOCK. NO LEAKING PRESENT AFTER THAT. PHYSICIAN NOTIFIED, PHYSICIAN THEN NOTIFIED THE SURGICAL TEAM. PATIENT WILL HAVE BROVIAC LINE REMOVED TOMORROW (DATE NOT SPECIFIED) AND HAVE A PAC PUT IN PLACE. THIS IS THE 3RD TIME THIS HAS HAPPENED TO THIS PATIENTS LINE. THE PRODUCT WAS NOT RETAINED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT WILL HAVE A BROVIAC LINE REMOVED AND HAVE A PAC PUT IN PLACE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OTHER THAN THE ADDITIONAL SURGERY DUE TO THIS OCCURRENCE.
Patient problems: No Code Available
MAUDE report 5435823 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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