Exodus 10525Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI H965105250), received between Feb 13, 2018 and Apr 23, 2025 — classified as 10 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Fracture” (18 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

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Fracture; Fracture

  A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WITH A BILIARY DRAINAGE CATHETER 8F 35 CM STD LOOP W/ RADIOPAQUE MARKER BAND. APPROXIMATELY 3 MONTHS POST PLACEMENT, THE END USER WAS REMOVING THE EXODUS BILIARY CATHETER. WHEN REMOVING THE CATHETER, THE CATHETER FRACTURED AT ALL THE HOLE LOCATIONS. THE DOCTOR WAS ABLE TO REMOVE ALL THE FRAGMENTS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT. ADDITIONAL INFORMATION: IT WAS CONFIRMED THE TIP HAD BEEN PLACED IN THE DUODENUM AND THE PATIENT HAD THEIR GALLBLADDER REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21891537 ↗
• MalfunctionMar 5, 2024Fracture; Fracture

  NEW INFORMATION PROVIDED: CONFIRMATION THAT THE BILIARY CATHETER WAS BEING USED AS AN INTERNAL DRAIN OF BILE INTO THE SMALL INTESTINE. NOTHING WAS BEING INFUSED THROUGH THE CATHETER. CONFIRMATION THAT THE TIP OF THE DRAINAGE CATHETER WAS PLACED IN THE PATIENT'S DUODENUM. CONFIRMATION THE PATIENT DID NOT HAVE ANY RESTRUCTURING OF THEIR GI TRACT DUE TO SURGERY OR TRAUMA, .E.G POST WHIPPLE OR HEPATICOJEJUNOSTOMY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18836890 ↗
• MalfunctionMar 5, 2024Fracture; Fracture

  DEVICE 2 OF 2: NEW INFORMATION PROVIDED: CONFIRMATION THAT THE BILIARY CATHETER WAS BEING USED AS AN INTERNAL DRAIN OF BILE INTO THE SMALL INTESTINE. NOTHING WAS BEING INFUSED THROUGH THE CATHETER. CONFIRMATION THAT THE TIP OF THE DRAINAGE CATHETER WAS PLACED IN THE PATIENT'S DUODENUM. CONFIRMATION THE PATIENT DID NOT HAVE ANY RESTRUCTURING OF THEIR GI TRACT DUE TO SURGERY OR TRAUMA, .E.G POST WHIPPLE OR HEPATICOJEJUNOSTOMY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18836886 ↗
• MalfunctionJun 22, 2023Fracture; Fracture

  IT WAS REPORTED WHEN REPLACING THE BILIARY CATHETER FROM AN EXODUS DRAINAGE CATH 8F BILIARY PIGTAIL STD - 35CM KIT. AT THE 90-DAY REPLACEMENT PROCEDURE, THE CATHETER DISINTEGRATED AND BROKE INTO SMALLER PIECES. ALL PIECES OF THE CATHETER WERE SUCCESSFULLY REMOVED. THE REPLACEMENT PROCEDURE WAS COMPLETED, USING A BSC BILIARY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184933 ↗
• MalfunctionDec 15, 2021Fracture; Fracture

  AN END USER REPORTED AN ISSUE WITH AN EXODUS BILIARY DRAINAGE CATHETER 8F 35CM STD LOOP W/ RADIOPAQUE MARKER BAND. PATIENT HAS BEEN RECEIVING BILIARY CATHETER EXCHANGES SINCE (B)(6) 2019 SINCE HE IS NOT A SURGICAL CANDIDATE DUE TO CHRONIC BILIARY STRICTURE AND UNABLE TO UNDERGO ANESTHESIA FOR SURGICAL ALTERNATIVE. THE CATHETER HAD BEEN PLACED IN (B)(6) 2021, AND WHEN ACCESSED ON (B)(6) 2021, IT WAS NOTED THE CATHETER TIP HAD DETACHED INSIDE THE PATIENT. THE FRACTURED 8FR EXODUS BILIARY DRAIN WAS SEEN UPON INITIAL FLUOROSCOPIC EXAM DURING A ROUTINE BILIARY TUBE EXCHANGE. THE TUBE WAS SUCCESSFULLY REMOVED AFTER SHEATH AND SNARE DEVICE USED. IT WAS REPLACED WITH ALTERNATIVE CATHETER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13011214 ↗
• MalfunctionOct 25, 2021Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED AN ISSUE WITH AN EXODUS BILIARY DRAINAGE CATHETER 8F 35CM STD LOOP W/ RADIOPAQUE MARKER BAND. THE CUSTOMER ROUTINELY PERFORMS A CATHETER EXCHANGE THREE MONTHS AFTER INDWELL OF A CATHETER. DURING THE INITIAL PLACEMENT OF THE REPLACEMENT BILIARY DRAINAGE CATHETER, THE CATHETER DISINTEGRATED INSIDE PATIENT RESULTING IN THE PHYSICIAN NEEDING TO SNARE THE FRAGMENTS OUT OF THE PATIENT. AN INCISION AT THE SITE WAS CREATED IN ORDER TO OPEN UP A PATH FOR THE CATHETER REMOVAL; THIS RESULTED IN AN INCREASED TRAUMA TO THE TRACT AND INCREASED BLEEDING AT THE SITE. FLOUROSCOPY WAS PERFORMED TO LOCATE THE FRAGMENTS, NOTING FRAGMENTS WERE LOCATED IN DUODENUM BUT STILL ATTACHED TO THE STRING. IT WAS ENSURED ALL FRAGMENTS WERE REMOVED. THE DRAINAGE CATHETER WAS REPLACED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. IT WAS INDICATED THE REPORTED DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR A DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12688275 ↗
• MalfunctionMay 28, 2021Fracture; Migration; Fracture; Migration

  AN END USER REPORTED AN ISSUE WITH AN EXODUS BILIARY DRAINAGE CATHETER 8F 35CM STD LOOP W/ RADIOPAQUE MARKER BAND. THE FOLLOWING WAS REPORTED: DR. ROMAN PLACED AN 8F EXODUS BILIARY DRAIN ON (B)(6) 2021. (B)(6) DID A DRAIN CHANGE ON THE SAME DRAIN ON (B)(6) 2021 AND NOTICED THAT THE DRAIN HAD FRAGMENTED AFTER HE PLACED THE .035 GUIDEWIRE AND TRIED TO PULL THE DRAIN. WHEN HE PULLED THE DRAIN TO REMOVE IT FROM THE PATIENT IT BROKE IN TWO PIECES, SEPARATING AT THE TIP. DR. CHAN WAS ABLE TO RETRIEVE BOTH PIECES DUE TO EACH PIECE BEING CLOSE TO THE SURFACE. THE TIP OF THE DRAIN WAS PLACED INSIDE THE BILIARY DUCT. AFTER REMOVING THE DRAIN, DR. CHAN THEN PLACED AN 8F BILIARY URESIL DRAIN. THE REPORTED DEVICE IHAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 11899946 ↗
• MalfunctionMay 26, 2021Fracture; Migration; Fracture; Migration

  AN END USER REPORTED AN ISSUE WITH A BILIARY DRAINAGE CATHETER 8F 35CM STD LOOP W/ RADIOPAQUE MARKER BAND. THE FOLLOWING WAS REPORTED: "DR.(B)(6) PLACED AN 8F EXODUS BILIARY DRAIN ON (B)(6) 2020. DR. (B)(6) DID A DRAIN CHANGE ON THIS SAME DRAIN ON MARCH 16, 2021 AND NOTICED THE DRAIN HAD FRAGMENTED INSIDE OF THE PATIENT IN HIS BILIARY DUCT. DR. (B)(6) ATTEMPTED TO SEND A .035 GUIDEWIRE THROUGH THE DRAIN, BUT COULD ONLY GET THE WIRE THROUGH THE HUB AND NOT THE ENTIRE LUMEN OF THE DRAIN. WHEN LOOKING AT THE WIRE ON FLUOROSCOPY, HE NOTICED THAT THE DRAIN HAD FRAGMENTED INTO 3 DIFFERENT PIECES: THE HUB, MIDDLE AND DISTAL END. TWO OF THE FRAGMENTS ARE STILL INSIDE THE PATIENT AFTER MULTIPLE FAILED ATTEMPTS TO REMOVE THE FRAGMENTS. THE ONLY PART OF THE DRAIN THAT WAS RECOVERED WAS THE HUB.THE TIP OF THE CATHETER WAS INSIDE THE BILIARY DUCT. THEY WERE AWARE THAT THE DRAIN DWELL TIME HAD BEEN OVER 7 MONTHS. IT WAS INDICATED A NEW OF THE SAME DEVICE WAS PLACED TO CONTINUE TREATMENT. ADDITIONAL INFORMATION PROVIDED REPORTED THAT AN ADDITIONAL ATTEMPT TO REMOVE THE FRAGMENTS WAS MADE. AFTER THE INITIAL ATTEMPT, DR. (B)(6) TRIED TO RETRIEVE THE DRAIN FRAGMENTS THROUGH AN ENDO PROCEDURE. THEY W

  Patient problems: Foreign Body In Patient

  MAUDE report 11890772 ↗
• MalfunctionApr 25, 2021Fracture; Fracture

  A NURSE REPORTED AN ISSUE WITH AN 8F 35CM EXODUS BILIARY DRAINAGE CATHETER, WHICH WAS USED UNDER AN EMERGENCY USE AUTHORIZATION (EUA). A PATIENT PRESENTED FOR A BILIARY DRAINAGE CHECK AND POSSIBLE EXCHANGE OR REMOVAL OF THE DRAIN. THE PATIENT HAD A SUCCESSFUL CAPPING TRIAL. WHILE A PHYSICIAN ATTEMPTED TO REMOVE THE EXISTING CATHETER OVER A WIRE, THE CATHETER SEVERED AND CAME OUT IN PIECES WITH REMAINING FRAGMENT IN THE PATIENT'S LIVER PARENCHYMA/ DUCTS AND THE BOWEL LOOP, THROUGH THE HEPATICOJEJUNOSTOMY. AN ATTEMPT WAS MADE TO RETRIEVE THE DEVICE FRAGMENT WITH A SNARE, AFTER PLACING A SAFETY WIRE ACROSS THE ANASTAMOSIS. THIS ATTEMPT WAS UNSUCCESSFUL AND THE FRAGMENT WAS ONLY, PARTLY, PULLED BACK INTO THE TRACT BUT THERE WAS AN INABILITY TO REMOVE THE "ATTACHING" TO THE DISTAL PART OF THE CATHETER. FURTHER ATTEMPTS WERE PERFORMED BY DILATING THE TRACT UP TO 14FR, AFTER UNSUCCESSFULLY ATTEMPTING AT 12 AND 10FR, PLACING A SNARE INTO THE TRACT TO CATCH THE FRAGMENT, USING RAT AND MAGILL FORCEPS, AND LASTLY, ATTEMPTING TO USE ALLIGATOR FORCEPS. UNFORTUNATELY, THE ALLIGATOR FORCEPS ONLY CAUSED THE FRAGMENT TO DISINTEGRATE FURTHER AND DURING THIS PROCESS, THE BENTSON WIRE BECAME ENTANGLE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11721791 ↗
• InjuryDec 11, 2020Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT A PATIENT'S EXODUS 8F BILIARY DRAINAGE CATHETER WAS OBSERVED THROUGH IMAGING TO HAVE SPLIT INTO TWO PIECES, RIGHT BY THE PIGTAIL INSIDE OF THE PATIENT'S LIVER. AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE THE CATHETER TIP (REQUIRING ADDITIONAL PATIENT SEDATION). THE DEVICE WAS NOT REPLACED AS THE DEVICE WAS BEING REMOVED AT END OF TREATMENT. IT WAS REPORTED THE PATIENT WAS POST-OP WHIPPLE. THERE WAS NO PERMANENT HARM OR INJURY TO THIS PATIENT DUE TO THIS EVENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10991866 ↗
• InjuryOct 20, 2020Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT A PATIENT'S EXODUS 8F BILIARY DRAINAGE CATHETER WAS OBSERVED THROUGH IMAGING TO HAVE SPLIT INTO TWO PIECES, RIGHT BY THE PIGTAIL INSIDE OF THE PATIENT'S LIVER. AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE THE CATHETER TIP (REQUIRING ADDITIONAL PATIENT SEDATION). THE DEVICE WAS NOT REPLACED AS THE DEVICE WAS BEING REMOVED AT END OF TREATMENT. IT WAS REPORTED THE PATIENT WAS POST-OP WHIPPLE. THERE WAS NO PERMANENT HARM OR INJURY TO THIS PATIENT DUE TO THIS EVENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10704567 ↗
• InjuryOct 19, 2020Fracture; Fracture

  AN ANGIODYNAMICS TERRITORY MANAGER REPORTED THAT A PATIENT'S EXODUS 8F BILIARY DRAINAGE CATHETER WAS OBSERVED THROUGH IMAGING TO HAVE SPLIT INTO TWO PIECES, RIGHT BY THE PIGTAIL INSIDE OF THE PATIENT'S LIVER. AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE THE CATHETER TIP (REQUIRING ADDITIONAL PATIENT SEDATION). THE DEVICE WAS NOT REPLACED AS THE DEVICE WAS BEING REMOVED AT END OF TREATMENT. IT WAS REPORTED THE PATIENT WAS POST-OP WHIPPLE. THERE WAS NO PERMANENT HARM OR INJURY TO THIS PATIENT DUE TO THIS EVENT. THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10702008 ↗
• InjuryAug 14, 2019Fracture; Fracture

  PHYSICIAN STATED THAT THE PATIENT CAME IN FOR THE EXCHANGE/UPSIZE OF AN 8F EXODUS BILIARY DRAINAGE CATHETER. DURING THE PROCEDURE, DURING THE ADVANCEMENT OF THE WIRE, THE TIP BROKE OFF, AT THE MID-PIGTAIL. SNARES WERE USED TO TRY TO EXTRACT THE TIP DURING THE PROCEDURE, HOWEVER IT WAS UNSUCCESSFUL AND THE TIP WAS THEN LEFT IN THE SMALL INTESTINE FOR THE PATIENT TO PASS ON HIS OWN. A 10F COOK BILIARY DRAIN WAS THEN PUT IN PLACE AND THE PROCEDURE CONCLUDED. THERE WAS NO PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8893030 ↗
• InjuryAug 14, 2019Fracture; Fracture

  PHYSICIAN STATED THAT THE PATIENT CAME IN FOR THE EXCHANGE/UPSIZE OF AN 8F EXODUS BILIARY DRAINAGE CATHETER, THIS DRAIN WAS ORIGINALLY PLACED ON (B)(6) 2019. DURING THE PROCEDURE, DURING THE ADVANCEMENT OF THE WIRE, THE TIP BROKE OFF, AT THE MID-PIGTAIL. SNARES WERE USED TO TRY TO EXTRACT THE TIP DURING THE PROCEDURE, HOWEVER IT WAS UNSUCCESSFUL AND THE TIP WAS THEN LEFT IN THE SMALL INTESTINE FOR THE PATIENT TO PASS ON HIS OWN. A 10F COOK BILIARY DRAIN WAS THEN PUT IN PLACE AND THE PROCEDURE CONCLUDED. THERE WAS NO PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THIS EVENT. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS AVAILABLE FOR RETURN TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8893019 ↗
• InjuryJul 16, 2019Fracture; Fracture

  AS REPORTED ON USER MEDWATCH # (B)(4): "PATIENT WAS UNDERGOING ROUTINE BILIARY CATHETER EXCHANGE. WHEN THE EXISTING DRAIN (INITIALLY PLACED APPROXIMATELY 3 MONTHS AGO) WAS WIRED DURING THE PROCEDURE, THE PIGTAIL PORTION OF THE CATHETER BROKE OFF IN THE SMALL BOWEL. EXTERNAL PORTION OF CATHETER WAS REMOVED AND NEW CATHETER PLACED. NO APPARENT HARM TO PATIENT. " IT HAS BEEN INDICATED THAT THE USED CATHETER WILL NOT BE RETURNED TO ANGIODYNAMICS.

  Patient problems: Foreign Body In Patient

  MAUDE report 8794412 ↗
• MalfunctionJun 25, 2019Use of Device Problem; Use of Device Problem

  AS REPORTED REGARDING AN 8F EXODUS BILIARY DRAINAGE CATHETER: DR. (B)(6), AN INTERVENTIONAL RADIOLOGIST, COMPLAINED THAT " THE DRAIN COULD NOT ASPIRATE OR FLUSH INSIDE THE PATIENT. HE SAID THAT IT SEEMED LIKE THE CATHETER WAS CLOSED OFF IN SOME PORTION OF THE LUMEN". THEY UPSIZED TO A 10F AND THE PROBLEM WENT AWAY. THE CATHETER HAD BEEN IMPLANTED FOR 7 DAYS. IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8731558 ↗
• MalfunctionJun 25, 2019Use of Device Problem; Use of Device Problem

  AS REPORTED REGARDING AN 8F EXODUS BILIARY DRAINAGE CATHETER: DR. (B)(6), AN INTERVENTIONAL RADIOLOGIST, COMPLAINED THAT " THE DRAIN COULD NOT ASPIRATE OR FLUSH INSIDE THE PATIENT. HE SAID THAT IT SEEMED LIKE THE CATHETER WAS CLOSED OFF IN SOME PORTION OF THE LUMEN". THEY UPSIZED TO A 10F AND THE PROBLEM WENT AWAY. THE CATHETER HAD BEEN IMPLANTED FOR 5 DAYS. IT HAS BEEN INDICATED THAT THE USED DEVICE WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8731556 ↗
• InjuryNov 15, 2018Fracture; Migration; Fracture; Migration

  AS REPORTED BY HOSPITAL IN (B)(6), CATHETER USED FOR INTERNAL/EXTERNAL BILIARY DRAINAGE HAS FRAGMENTED WITHIN THE PATIENT. CATHETER HAD BEEN PLACED (B)(6) 2018 AND WAS REMOVED (B)(6) 2018. CATHETER TIP HAD BEEN PLACED IN THE DUODENUM. THE FRACTURED TIP WAS LEFT IN THE PATIENT TO PASS THROUGH THE GI SYSTEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 8073175 ↗
• InjuryNov 15, 2018Fracture; Migration; Fracture; Migration

  AS REPORTED BY HOSPITAL IN (B)(6), CATHETER USED FOR INTERNAL/EXTERNAL BILIARY DRAINAGE HAS FRAGMENTED WITHIN THE PATIENT. CATHETER HAD BEEN PLACED (B)(6) 2018 AND WAS REMOVED (B)(6) 2018. CATHETER TIP HAD BEEN PLACED IN THE DUODENUM. THE FRACTURED TIP WAS LEFT IN THE PATIENT TO PASS THROUGH THE GI SYSTEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 8073172 ↗
• InjuryNov 15, 2018Fracture; Migration; Fracture; Migration

  AS REPORTED BY HOSPITAL IN (B)(6), CATHETER USED FOR INTERNAL/EXTERNAL BILIARY DRAINAGE HAS FRAGMENTED WITHIN THE PATIENT. CATHETER HAD BEEN PLACED (B)(6) 2018 AND WAS REMOVED (B)(6) 2018. CATHETER TIP HAD BEEN PLACED IN THE DUODENUM, BUT HAD RETRACTED ON EXCHANGE, SO TIP WAS WITHIN THE RIGHT MAIN INTRAHEPATIC DUCT. THE FRACTURED TIP WAS EXTRACTED THROUGH A SHEATH USING A SNARE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8073171 ↗
• InjuryFeb 13, 2018Crack; Crack

  AS REPORTED BY HOSPITAL IN (B)(6), BILIARY LINE PLACED (B)(6) 2017. PHYSICIAN HAD TROUBLE UNLOCKING THE PIGTAIL DURING REMOVAL OF THE DRAINAGE CATHETER ON (B)(6) 2018. HE THEN ADVANCED THE WIRE, GOT THROUGH TO THE DISTAL TIP OF THE CATHETER AND PULLED BACK. THE DISTAL TIP OF THE PIGTAIL THEN DETACHED FROM THE SHAFT OF THE CATHETER. THE PATIENT WAS FROM A PALLIATIVE CARE UNIT. THE PHYSICIAN SENT THE PATIENT BACK TO PALLIATIVE CARE FOR OBSERVATION WITH THE PIGTAIL TIP STILL IN. AN X-RAY IMAGE WAS PROVIDED BUT NO SAMPLE WILL BE RETURNED FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7267655 ↗