CODMAN AP-03000HRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886704043591), received between Oct 24, 2017 and Apr 1, 2025 — classified as 2 deaths, 21 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

15 other recalls cover devices cleared under the same FDA submission (P890055); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTERA ONCOLOGY RECEIVED A REPORT OF A REVISION THAT WAS PERFORMED. THE REVISION WAS DUE TO THE PATIENT DEVELOPING A PSEUDOANEURYSM OF HER COMMON HEPATIC ARTERY AND REQUIRING A STENT. THE PHYSICIAN ATTACHED A TAPERED CATHETER TO THE ALREADY IMPLANTED HEPATIC ARTERY INFUSION PUMP AND INSERTED CATHETER INTO THE SPLENIC ARTERY. NO NEW PUMP WAS IMPLANTED. THE PHYSICIAN REPORTED EVERYTHING WENT WELL.

  Patient problems: Pseudoaneurysm

  MAUDE report 21743152 ↗
• MalfunctionOct 18, 2024Obstruction of Flow; Obstruction of Flow

  INTERA ONCOLOGY, RECEIVED A REPORT FROM CLINIC OF HIGH RESIDUALS OF GLYCERIN IN THE PUMP. THE CLINIC ORIGINALLY DISPENSED 30ML OF GLYCERIN TO THE PUMP. ON (B)(6) 2024, ON THE PATIENT'S SCHEDULED 6 WEEK GLYCEROL FLUSH, THE CLINIC FLUSHED 26ML OF RESIDUAL. THE GLYCERIN LOT NUMBER THE CLINIC USED WAS 0004605665 AND THE EXPIRATION DATE WAS OCTOBER 2026. THIS LOT WAS MANUFACTURED BY ALK LABORATORIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486849 ↗
• MalfunctionOct 18, 2024Obstruction of Flow; Obstruction of Flow

  INTERA ONCOLOGY, RECEIVED A REPORT FROM CLINIC OF HIGH RESIDUALS OF GLYCERIN IN THE PUMP. THE CLINIC ORIGINALLY DISPENSED 30ML OF GLYCERIN TO THE PUMP. ON (B)(6) 2024, ON THE PATIENT'S SCHEDULED 9 WEEK GLYCEROL FLUSH, THE CLINIC FLUSHED 30 ML OF RESIDUAL. THE CLINIC COMPLETED FLOW STUDY ON (B)(6) 2024 AND NO OBSTRUCTION WAS FOUND. THE GLYCERIN LOT NUMBER THE CLINIC USED WAS 0004605665 AND THE EXPIRATION DATE WAS OCTOBER 2027. THIS LOT WAS MANUFACTURED BY ALK LABORATORIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486781 ↗
• InjuryNov 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE REPORT: VERHEIJ FS, KUHLMANN KFD, SILLIMAN DR, SOARES KC, KINGHAM TP, BALACHANDRAN VP, DREBIN JA, WEI AC, JARNAGIN WR, CERCEK A, KOK NFM, KEMENY NE, D'ANGELICA MI. COMBINED HEPATIC ARTERIAL INFUSION PUMP AND SYSTEMIC CHEMOTHERAPY IN THE MODERN ERA FOR CHEMOTHERAPY-NAIVE PATIENTS WITH UNRESECTABLE COLORECTAL LIVER METASTASES. ANN SURG ONCOL. 2023 AUG 28. DOI: 10.1245/S10434-023-14073-3. EPUB AHEAD OF PRINT. PMID: 37639032. THE LITERATURE SOURCE REPORTED A RETROSPECTIVE STUDY OF FIFTY-EIGHT CHEMOTHERAPY-NAIVE PATIENTS WERE IDENTIFIED OUT OF 546 PATIENTS WITH UNRESECTABLE CRLM (COLORECTAL LIVER METASTASES) MANAGED WITH HAI BETWEEN 2003 AND 2019. THE FOLLOWING ADVERSE EVENTS WERE REPORTED IN THIS STUDY: SURGICAL SITE INFECTION, ANASTOMOTIC LEAK (INTESTINAL), ILEUS (PARALYTIC), PUMP-RELATED INFECTION, FEVER.

  Patient problems: Fever; Obstruction/Occlusion; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 18117404 ↗
• InjuryAug 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS DISCUSSED WITH VARIOUS OFFICIALS AT A HEALTHCARE PROVIDER THAT AN ADVERSE EVENT MAY HAVE OCCURRED WITH THE USE OF A CODMAN 3000 HIGH FLOW INFUSION PUMP. IMPLANT DATE WAS (B)(6) 2018. THE SURGEON WHO EXPLANTED THE DEVICE STATED TO INTERA THAT THE DEVICE WAS EXPLANTED DUE TO 'CONCERN FOR INFECTION.' ADDITIONAL CONVERSATIONS WITH THE PROVIDER STATED THAT THE CLINICAL NOTES WERE 'UNCLEAR,' BUT THERE ALSO APPEARED TO BE A POSSIBLE EXTRAVASATION EVENT. THEREFORE, THE HEALTHCARE PROVIDER REQUESTED A DEVICE EVALUATION TO DETERMINE IF A MALFUNCTION HAD OCCURED OR NOT. THE EXTRAVASATION EVENT WAS REPORTED TO BE 04/18/2023. EXPLANT DATE WAS REPORTED TO BE (B)(6) 2023. IT WAS REPORTED THAT THE MITOMYCIN AND FUDR (FLOXURIDINE) WERE INFUSED AT THE TIME OF THE EVENT.

  Patient problems: Extravasation

  MAUDE report 17577746 ↗
• MalfunctionAug 18, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT RETURNED A CARD FROM THE JUNE 2023 ROUTINE IMPLANT TRACKING MAILING STATING THE FOLLOWING: "PUMP HAS NOT BEEN REMOVED BUT DOES NOT WORK." NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17577202 ↗
• InjuryJun 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RETURNED DEVICE TRACKING CARD STATING "PLEASE MAKE SURE, THE PUMP IS WORKING. I GOT THE PUMP, WHICH NEVER WORKED." PATIENT WROTE THAT PUMP WAS PREVIOUSLY EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 11917084 ↗
• InjuryMay 26, 2021Obstruction of Flow; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available

  DEVICE TRACKING CARD WAS RETURNED AND STATED "NO LONGER BEING USED, NOT PATENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882788 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE TRACKING CARD WAS RECEIVED FROM PATIENT. WRITTEN ON THE CARD WAS "NOTE - PUMP CAUSED INFECTION." THE DEVICE WAS EXPLANTED (B)(6) 2019. THE DATE WRITTEN ON THE CARD BY THE INITIAL REPORTER WAS (B)(6) 2021, THE CARD WAS RECEIVED IN THE MAIL BY INTERA ONCOLOGY ON 04/28/2021. THE PHYSICIAN'S OFFICE WAS CONTACTED AND MORE INFORMATION WAS OBTAINED REGARDING THE ADVERSE EVENT. AS PROVIDED BY THE PHYSICIAN'S OFFICE, THE PATIENT DEVELOPED A CELLULTIS INFECTION (B)(6) ON THE INCISION OVER THE PUMP APPROXIMATELY 8 MONTHS AFTER IMPLANT. THE PATIENT WAS PLACED ON SUPPRESSIVE ANTIBIOTICS WITH CEPHALOSPORIN FOR 1 YEAR PRIOR TO REMOVAL OF HAI PUMP BECAUSE OF CONTINUED INFECTION (DESCRIBED AS 'RARE (B)(6)'). INFECTION WAS RESOLVED AFTER THE EXPLANT OF THE PUMP. THE PHYSICIAN'S OFFICE DESCRIBED THE RELATIONSHIP BETWEEN THE PUMP AND THE INFECTION AS "MUTUAL EXCLUSIVE."

  Patient problems: Cellulitis

  MAUDE report 11882338 ↗
• DeathMay 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVICE TRACKING CARD WAS RETURNED TO INTERA ONCOLOGY; FAMILY MEMBER WROTE "DECEASED 2004 FROM STAPH INFECTION FROM PUMP."

  Patient problems: Bacterial Infection

  MAUDE report 11871328 ↗
• InjuryMay 21, 2021Break; Migration; Migration

  PHONE DIALOG WITH A PATIENT FAMILY MEMBER WAS CONDUCTED ON (B)(6) 2021: FAMILY MEMBER DESCRIBED THE COMPLAINT AS A CATHETER DISLODGMENT, WHICH OCCURED APPROXIMATELY 3 YEARS AGO.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867047 ↗
• InjuryMay 17, 2021Obstruction of Flow; Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION WAS PROVIDED FROM PATIENT'S HEALTH CARE PROVIDER. THE HEALTH CARE PROVIDER STATED THAT THE PATIENT HAD A CODMAN 3000 DRUG DELIVERY PUMP IMPLANTED FOR HEPATIC ARTERIAL INFUSION. THEY STATED THAT FIVE DAYS AFTER IMPLANTATION, PATIENT HAD POST-SURGERY ABNORMAL HEPATIC FLOW. A DIAGNOSTIC ARTERIOGRAM FOUND THAT THE COMMON HEPATIC ARTERY WAS DISSECTED AND OCCLUDED. VASCULAR DISSECTION AND SUBSEQUENT OCCLUSION/THROMBOSIS MAY OCCUR DUE TO MALPOSITION OF THE CATHETER IN ARTERY DURING IMPLANT. VESSEL THROMBOSIS IS A KNOWN PROCEDURAL COMPLICATION AS LISTED ON THE LABELING OF THE CODMAN 3000. HEPARINIZED SALINE WAS BEING ADMINISTERED IN THE PUMP AT THE TIME OF THE ADVERSE EVENT. EXPLANT DATE WAS NOT PROVIDED.

  Patient problems: Insufficient Information; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 11838720 ↗
• InjuryMay 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT RESPONDED TO DEVICE TRACKING MAILING STATING THAT PUMP WAS REMOVED 4 MONTHS AFTER IMPLANT BECAUSE IT IRRITATED HER. SHE STATED SHE RECEIVED CHEMOTHERAPY FOR THE 4 MONTHS AND IS CURRENTLY DISEASE FREE. IMPLANT DATE WAS (B)(6) 1998.

  Patient problems: Discomfort

  MAUDE report 11829061 ↗
• MalfunctionMay 14, 2021No Flow; No Flow

  THE PATIENT CALLED THE CLINICAL CALL LINE IN RESPONSE TO THE DEVICE TRACKING MAILING TO STATE THAT HIS CODMAN PUMP HAD BEEN PREVIOUSLY REMOVED. HE STATED THAT THE PUMP WAS "PLUGGED UP," BUT NO LONGER NEEDED, SO IT WAS REMOVED IN 2007.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11828958 ↗
• InjuryApr 30, 2021Complete Blockage; Complete Blockage

  PATIENT FAMILY MEMBER CALLED CLINICAL CALL LINE STATING THAT PATIENT'S HEPATIC ARTERY INFUSION PUMP, IMPLANTED (B)(6) 2017, CAN NO LONGER BE USED. THE PATIENT'S CATHETER HAS "EMBOLIZED" ACCORDING TO THE PATIENT'S FAMILY MEMBER. AS STATED BY THE FAMILY MEMBER, THE REFILLING PHYSICIAN SAID THE EMBOLISM WAS CAUSED BY THE PATIENT'S RADIATION TREATMENTS, AND THAT THE PUMP MAY NO LONGER BE UTILIZED FOR THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11758308 ↗
• MalfunctionApr 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PUBLICATION ''COMBINED SYSTEMIC AND HEPATIC ARTERY INFUSION PUMP CHEMO-THERAPY AS A LIVER-DIRECTED THERAPY FOR COLORECTAL LIVER METASTASIS-REVIEW OF LITERATURE AND CASE DISCUSSION," CANCERS (2021) VOLUME 13 WAS PUBLISHED AND MADE AVAILABLE ONLINE. IT DECRIBES A CASE STUDY IN WHICH A HEPATIC ARTERY INFUSION PUMP "MALFUNCTIONED."

  Patient problems: Insufficient Information

  MAUDE report 11676331 ↗
• MalfunctionApr 15, 2021Complete Blockage; Complete Blockage

  INTERA ONCOLOGY CONTACTED THE HOSPITAL TO REVIEW DEVICE TRACKING DATA AND WAS SUBSEQUENTLY INFORMED THAT A PATIENT HAD A 'DEFECTIVE' CODMAN PUMP. INTERA ENGAGED IN FURTHER DIALOG WITH THIS HOSPITAL, AND IT WAS COMMUNICATED THAT THE PUMP BEGAN RETURNING PARTIAL OR FULL VOLUME OF INFUSATE (FIRST GLYCERIN, LATER HEPARIN SALINE), INDICATIVE OF A LACK OF FLOW AND INFUSATE DELIVERY OVER THE REFILL INTERVAL. THE REFILL INTERVALS WERE AS FOLLOWS: (B)(6) 2018 - GLYCERIN, (B)(6) 2018 - GLYCERIN, (B)(6) 2019 - GLYCERIN , (B)(6) 2019 - GLYCERIN (8.5 CCS OF GLYCERIN WERE RETURNED), (B)(6) 2020 - HEPARIN SALINE (10.5 CCS OF GLYCERIN WERE RETURNED), (B)(6) 2020 - HEPARIN SALINE (27 CCS OF HEPARIN SALINE WERE RETURNED), (B)(6) 2020 - (23 CCS OF HEPARIN SALINE WERE RETURNED), (B)(6) 2020 (25.5 CCS OF HEPARIN SALINE WERE RETURNED), (B)(6) 2020 (27 CCS OF HEPARIN SALINE WERE RETURNED), SALINE REFILLS WERE PERFORMED EVERY TWO WEEKS UNTIL (B)(6) 2020, WITH THE MAJORITY OF THE VOLUME RETURNED EACH TIME. IT WAS DISCUSSED THAT THE REFILL INTERVAL BETWEEN (B)(6) 2018 AND (B)(6) 2019 WAS CALCULATED TO BE APPROXIMATELY 259 DAYS BASED ON A PERCEIVED FLOW RATE OF 0.104 ML/DAY. THE PATIENT HAD SEVERAL APPOINTME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676255 ↗
• InjuryDec 18, 2020Migration; Migration

  PATIENT ADMITTED (B)(6) 2020 WITH A CODMAN PUMP PLACE 2 YEARS AGO AT ANOTHER INSTITUTION. REPORTER DOES NOT SUSPECT PUMP HAS MALFUNCTIONED AS THE PATIENT HAD IT REFILLED 2 WEEKS AGE AND WAS ACTIVELY RECEIVING CHEMOTHERAPY. REPORTER SUSPECTS THAT THE CATHETER TIP BECAME DISLODGED FROM THE LUMEN OF THE ARTERY. THEY REQUESTED A SPECIAL BOLUS NEEDLE SO THEY MAY INVESTIGATE FURTHER. REPORTER INSTITUTION PERFORMED A PUMP STUDY/ANGIOGRAM TO CONFIRM THAT THE PUMP CATHETER TIP WAS PARTIALLY OUT OF THE LUMEN ON THE GASTRODUODENAL ARTERY (GDA). WHEN THE PUMP WAS ACCESSED AND CONTRAST WAS INJECTED INTO THE CATHETER, CONTRAST FILLED THE HEPATIC ARTERIES BUT ALSO EXTRAVASATED OUTSIDE OF THE VESSEL LUMEN. A STENT GRAFT WAS PLACED ACROSS THE GASTRODUODENAL ARTERY STUMP IN ORDER TO EXCLUDE THE HEPATIC ARTERY INFUSION CATHETER, AND PREVENT ANY FURTHER BLEEDING FROM THE PARTIALLY MALPOSITION CATHETER TIP. AT THE TIME OF THIS INVESTIGATION AND REPORT, PATIENT WAS REPORTED AS STABLE.

  Patient problems: Extravasation

  MAUDE report 11039479 ↗
• InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING MADE UPON IDENTIFYING AN ABSTRACT IN THE 2020 ACG ANNUAL MEETING ABSTRACTS, OCTOBER 2020 VOLUME 115, PUBLISHED ONLINE 02 NOVEMBER 2020. ABSTRACT TITLED: HEMOBILIA DUE TO ARTERIOBILIARY FISTULA FROM A HEPATIC ARTERY INFUSION PUMP PSEUDOANEURYSM. THE ABSTRACT INCLUDED DETAILS OF A POSSIBLE ADVERSE EVENT INVOLVING HEPATIC ARTERY INFUSION THERAPY THAT MAY BE DEVICE-RELATED. SPECIFICALLY ACCORDING TO THE ABSTRACT: CT DEMONSTRATED A 36 MM HYPOATTENUATING COLLECTION AT THE TIP OF THE HEPATIC ARTERY PUMP CAUSING BILIARY DUCT COMPRESSION AND UPSTREAM DILATION. ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) WAS PERFORMED WHICH DEMONSTRATED A MODERATE BILIARY STRICTURE AT THE LEVEL OF THE HAIP TIP AND A PLASTIC BILIARY STENT WAS PLACED. PATIENT RE-PRESENTED 3 WEEKS LATER WITH INCREASED ABDOMINAL PAIN, MELENA, AND JAUNDICE. CT ANGIOGRAM (CTA) DEMONSTRATED A 26 MM THROMBOSED PSEUDOANEURYSM IN THE GDA AT THE TIP OF THE HAIP WITHOUT ACTIVE BLEEDING. REPEAT ERCP SHOWED HEMOBILIA AND CLOTS WITH A 20 MM CAVITY SEEN IN THE MIDDLE THIRD OF THE BILE DUCT. A COVERED METAL STENT WAS PLACED ACROSS THIS AREA. PATIENT PRESENTED 10 DAYS LATER WITH RECURRENT SYMPTOMS AND UNDERWENT

  Patient problems: Gastrointestinal Hemorrhage; Pseudoaneurysm

  MAUDE report 10929604 ↗
• InjuryNov 24, 2020Migration or Expulsion of Device; Malposition of Device

  AN ARTICLE PUBLISHED IN THE JOURNAL OF SURGICAL ONCOLOGY, 23 OCTOBER 2020: "SAFETY AND FEASIBILITY OF INITIATING A HEPATIC ARTERY INFUSION PUMP CHEMOTHERAPY PROGRAM FOR UNRESECTABLE COLORECTAL LIVER METASTASES: A MULTICENTER, RETROSPECTIVE COHORT STUDY." THE STUDY INCLUDED PATIENTS FROM 2003-2017 AND INCLUDED PUMP-RELATED ADVERSE EVENTS. THESE EVENTS MAY OR MAY NOT HAVE BEEN REPORTED TO THE FDA IN PREVIOUS MDR REPORTS. PUMP-RELATED ADVERSE EVENTS THAT WERE REPORTED INCLUDE: PUMP POCKET (N=14), INFECTION (N=7), HEMATOMA (N=2), MIGRATION (N=2), UNSPECIFIED (N=2), HEPATIC ARTERIAL SYSTEM (N=10), THROMBOSIS (N=2), INCOMPLETE PERFUSION (N=4), BLEEDING (N=4), CATHETER (N=3). LONG TERM COMPLICATIONS REPORTED INCLUDE: BILIARY SCLEROSIS (N=13), OTHER (N=4), DUODENAL ULCER (N=1), DELAYED PUMP INFECTION (N=2), PUMP FLIPPED REQUIRING REOPERATION (N=1).

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Stomach Ulceration; Thrombosis; Unspecified Infection

  MAUDE report 10892059 ↗
• MalfunctionOct 20, 2020Failure to Infuse; Failure to Infuse

  CALL RECEIVED TO THE CLINICAL CALL LINE REGARDING A HEPATIC ARTERY INFUSION PUMP WAS THAT WAS NOT FLOWING. THE PATIENT HAS BEEN RECEIVING GLYCEROL SINCE APRIL 2020. HE WAS ON A DOSE OF GLYCEROL THAT WAS CAUSING THE PUMP TO FLOW TOO SLOW EVEN WITH GLYCEROL. THE FORMULA WAS CHANGED TO 50% W/V SOLUTION AND THE PUMP BEGAN FLOWING AT THE EXPECTED FLOW RATE. TWO WEEKS PRIOR, THE PATIENT WAS CHANGED TO HEPARINIZED SALINE. THE PUMP RESERVOIR WAS FLUSHED PER THE IFU INSTRUCTIONS, HOWEVER, THE CATHETER WAS NOT FLUSHED AS IT WAS DIFFICULT TO PUSH FLUID THROUGH THE SPECIAL BOLUS NEEDLE. 30MLS OF SALINE WAS RETURNED FROM THE PUMP UPON REFILL. CLINICAL INSTRUCTED THE FACILITY TO USE A FIBRINOLYTIC AGENT TO ATTEMPT TO DECLOT THE TIP OF THE CATHETER. THE PATIENT RETURNED FOR AN APPOINTMENT LATER AND FLOW WAS RESTORED TO WITHIN SPECIFICATION OF THE PUMP. NO HARM HAS COME TO THE PATIENT DURING THIS COURSE OF ACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10707775 ↗
• InjuryFeb 20, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  A REPORT FROM THE FIELD INDICATED THAT THE CODMAN 3000 30ML (AP03000H/C19731/15445) CONSTANT FLOW IMPLANTABLE DRUG PUMP ONLY DELIVERED 4ML OF CHEMOTHERAPY DURING THE FIRST TWO-WEEK CYCLE AND 1ML DURING THE NEXT CYCLE. THE CATHETER WAS EASILY FLUSHED USING THE SPECIAL BOLUS NEEDLE, INDICATING THERE WAS NO CLOTTING OF THE CATHETER. THE REPORTING CLINICAL SPECIALIST INSTRUCTED THE SITE TO RINSE THE PUMP TWICE WITH INJECTABLE SALINE THE NEXT TIME THE PATIENT IS IN THE OFFICE TO DETERMINE IF THE FLOW ISSUE HAS RESOLVED. THE PUMP WAS IMPLANTED IN (B)(6) 2017. THE PATIENT INITIALLY RECEIVED SIX CYCLES OF CHEMOTHERAPY AND THEN GLYCERIN WAS PLACED IN THE PUMP UNTIL (B)(6) 2019. WHEN THE SITE RESTARTED THE CHEMOTHERAPY, THE PUMP ONLY DELIVERED 4ML DURING THE FIRST TWO-WEEK CYCLE AND THEN 1ML DURING THE FOLLOWING CYCLE. ADDITIONAL INFORMATION RECEIVED ON 10-FEB-2020 INDICATED THAT THE ISSUE STARTED IN (B)(6) 2019 WHEN THEY RESTARTED CHEMOTHERAPY AFTER DELIVERING GLYCEROL FOR TWO YEARS FOLLOWING SIX INITIAL CYCLES OF CHEMOTHERAPY. THE PATIENT ONLY RECEIVED 0.43ML OF DRUG PER DAY WHEN SHE WAS SUPPOSED TO RECEIVE 1.2ML PER DAY. IT WAS REPORTED THAT THE LAST REFILL PROCEDURE WAS PERFORMED ACCORDI

  Patient problems: No Code Available

  MAUDE report 9732114 ↗
• MalfunctionNov 1, 2019No Flow; No Flow

  AS REPORTED BY A PATIENT VIA HIS PATIENT TRACKING CARD WITH A NOTE THAT SAYS ¿PUMP DOES NOT WORK! PUMP STILL IN, DOES NOT WORK.¿ CLARIFICATION WAS RECEIVED BY THE NATIONAL CLINICAL SPECIALIST, WHO SPOKE WITH THE PATIENT THAT THERE WAS A ¿PUMP LEAK¿ ON THE FIRST PUMP, A CODMAN MODEL 3000 30ML HIGH FLOW PUMP (SERIAL# AP03000H, (B)(4) THAT WAS IMPLANTED ON 30-MAY-2017. THEY TOOK IT OUT AND PUT IN ANOTHER CODMAN MODEL 3000 ¿ 30ML VOLUME, HIG (AP03000H, SERIAL# (B)(4) ON (B)(6) 2017. THE PATIENT DID NOT KNOW THE SPECIFIC ORIGIN OF THE LEAK. THE PUMP IS SCHEDULED TO BE EX-PLANTED IN (B)(6) 2020. THE PUMP WAS IMPLANTED TO TREAT CANCER. ONE DOSE OF CHEMOTHERAPY DRUG FUDR (FLUORODEOXYURIDINE) WAS RECEIVED. THE REMAINDER OF THE TIME THE PUMP HAD HEPARINIZED SALINE. THE PATIENT IS CURRENTLY NOT RECEIVING ANY MEDICATION AND DOES NOT HAVE CANCER. THE PATIENT HAS NOT EXPERIENCED ANY SYMPTOMS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9268410 ↗
• DeathJun 26, 2019Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  THE EVENT WAS REPORTED AS A WRITTEN NOTE ON A PATIENT FOLLOW-UP LETTER BY THE PATIENT¿S SPOUSE. IT WAS REPORTED THAT THE 30ML HIG MODEL 3000 CODMAN CONSTANT FLOW IMPLANTABLE PUMP (AP03000H / LOT#: 15705) IMPLANTED IN THE PATIENT ON (B)(6) 2018 CAUSED AN ULCER IN THE PATIENT THAT RESULTED IN A MAJOR ARTERY PERFORATION. THE PUMP WAS EXPLANTED ON (B)(6) 2018. THE PATIENT UNDERWENT MAJOR SURGERY TO REPAIR THE DAMAGE FROM THE PUMP WHICH ULTIMATELY RESULTED IN THE DEATH OF THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Death; No Code Available; Perforation of Vessels; Ulcer

  MAUDE report 8737551 ↗
• InjuryJul 25, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A CODMAN 3000 PUMP (AP03000H/15501) THAT HAD BEEN IMPLANTED ON (B)(6) 2017, WAS EXPLANTED FROM A PATIENT DUE TO INFECTION. THE PATIENT PRESENTED WITH REDNESS, PAIN, SWELLING, AND WARMTH AROUND THE PUMP ON (B)(6) 2018 AND IT WAS NOTED THAT THE PATIENT HAD AN INFECTED PUMP POCKET. THE INFECTION WAS LOCATED ON THE PATIENT¿S SKIN AND SOFT TISSUES. IN ADDITION TO EXPLANTING THE PUMP, THE PATIENT¿S INFECTION WAS TREATED WITH IV ABX AND PO ABX. THE INFECTION RESOLVED ON (B)(6) 2018. THE PATIENT WAS NOT IMPLANTED WITH A NEW PUMP AND THE PATIENT¿S STATUS IS CURRENTLY IMPROVING AS THE CANCER IS IN REMISSION AND HEPATIC INSUFFICIENCY. GLYCEROL WAS IN THE PUMP AT THE TIME OF EXPLANT. REPORTEDLY, THE PATIENT HAS A MEDICAL HISTORY OF CHOLANGIO CA, OBESITY, HEPATIC INSUFFICIENCY, DEPRESSION, ANXIETY, AND CDIF INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 7718085 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P890055. One submission often covers many models, so check the product and lot details in each record.

• Z-2580-2026 · May 11, 2026 · Completed
  Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
• Z-1522-2022 · Jul 10, 2022 · Terminated
  INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
• Z-1572-2014 · Nov 10, 2015 · Terminated
  MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for th
• Z-1571-2014 · Nov 10, 2015 · Terminated
  MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for th
• Z-1684-2015 · Mar 5, 2015 · Terminated
  CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit cont
• Z-2300-2013 · Aug 13, 2013 · Terminated
  MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for th
• Z-2293-2013 · Aug 13, 2013 · Terminated
  MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intr
• Z-2299-2013 · Aug 13, 2013 · Terminated
  MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for th
• Z-2295-2013 · Aug 13, 2013 · Terminated
  MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal del
• Z-2297-2013 · Aug 13, 2013 · Terminated
  MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intr
• Z-2296-2013 · Aug 13, 2013 · Terminated
  MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intra
• Z-2298-2013 · Aug 13, 2013 · Terminated
  MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intra
• Z-2294-2013 · Aug 13, 2013 · Terminated
  MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal
• Z-1690-2013 · Jun 7, 2013 · Terminated
  MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal de
• Z-1691-2013 · Jun 7, 2013 · Terminated
  MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the in