CODMAN AP-03000MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704043614), received between May 17, 2021 and Jan 24, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 24, 2022Infusion or Flow Problem; Infusion or Flow Problem

  A CALL TO THE CLINICAL CALL LINE BY A HEALTHCARE PROVIDER WAS RECEIVED STATING THAT A PATIENT ARRIVED AT THE HOSPITAL AND ADMITTED TO THE ICU OVERNIGHT ON (B)(6)2021. AS DESCRIBED BY CALLER, THE PATIENT WAS "CONFUSED, COMBATIVE, DISORIENTATED" AND WAS GIVEN NARCAN WHEN HE ARRIVED. ACCORDING TO THE CALLER, THE PATIENT HAS A CODMAN PUMP AND THE LAST REFILL DATE WAS (B)(6)2021 AND THE PATIENT WAS ADMINISTER 30 ML OF MORPHINE IN PUMP DOSED AS 8 MG PER DAY. THE CALLER STATED THE PATIENT MAY HAVE FALLEN AT HOME AND HAS BRUISE AT PUMP SITE. THE PATIENT RESPONSE TO NARCAN WAS NOT CONFIRMED BY THE ICU STAFF. INTERA CLINICAL SPOKE TO THE ICU STAFF MULTIPLE TIMES ON (B)(6)2021 AND INSTRUCTED THEM TO EMPTY THE PUMP. INTERA CLINICAL PERSONNEL OFFERED TO TRAVEL TO THE ICU SITE TO ASSIST WITH ACCESSING THE PUMP, BUT THE OFFER WAS DECLINED. THE ICU ATTEMPTED TO ACCESS THE PUMP TO EMPTY IT USING A 22 GAUGE NEEDLE THAT WAS NOT FROM AN INTERA REFILL KIT. WHEN INITIALLY ACCESSED, THE ICU STAFF REPORT NO INFUSATE WAS RETURNED. THE ICU STAFF LATER ATTEMPTED TO RE-ACCESS THE PUMP AND ASPIRATED AND RECEIVED 0.5-1 CC OF INFUSATE. THEY REPORTED THAT THE PATIENT WAS PLACED ON A FENTANYL DRIP TO TREAT SUSPECT

  Patient problems: Confusion/ Disorientation

  MAUDE report 13338768 ↗
• InjuryMay 25, 2021Material Frayed; Adverse Event Without Identified Device or Use Problem; Material Frayed; Adverse Event Without Identified Device or Use Problem

  EXPLANTING PHYSICIAN'S OFFICE PROVIDED OPERATING REPORT FOR WHEN THE DEVICE WAS PREVIOUSLY EXPLANTED. PATIENT DIAGNOSES WAS POSTLAMINECTOMY SYNDROME, LUMBAR SPINE, WITH SEVERE INTRACTABLE PAIN. OPERATING REPORT STATED THAT THE ARROW (NOW CODMAN) PUMP WAS IMPLANTED WITH A DACRON POUCH. THE DACRON POUCH, THE PUMP, AND CATHETER WERE REMOVED AND REPLACED WITH A MEDTRONIC PUMP. THE CATHETER APPEARED TO HAVE BEEN FRAYED AND WAS CUT WITH SCISSORS AND TIED OFF. THE CATHETER THAT WAS FRAYED WAS NOT IDENTIFIED AS A CODMAN CATHETER OR OTHER CATHETER IN THE OPERATIVE REPORT. THE OPERATIVE REPORT DID NOT IDENTIFY ANY OTHER VISIBLE MECHANICAL DAMAGE TO THE DEVICE. THE EXPLANTING PHYSICIAN'S OFFICE STATED THAT PATIENT IS NO LONGER SEEN AT THAT PRACTICE.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 11880482 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S HEALTHCARE PROVIDER WAS CONTACTED TO OBTAIN ADDITIONAL INFORMATION PERTAINING TO THE ADVERSE EVENT. THE HEALTHCARE PROVIDER SUGGESTED THAT THE ADVERSE EVENT WAS CELLULITIS, BUT WAS UNABLE TO POVIDE FURTHER DETAILS AND DID NOT SPECIFY WHICH PUMP WAS ASSOCIATED WITH THE INFECTION. THE PATIENT WAS PRESCRIBED MORPHINE FOR PAIN RELIEF. THE PATIENT'S MEDICAL RECORDS WERE UNAVAILABLE FOR FURTHER CONFIRMATION OF THE ADVERSE EVENT. EXPLANT DATE WAS NOT PROVIDED.

  Patient problems: Cellulitis; Inadequate Pain Relief

  MAUDE report 11838734 ↗

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-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-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-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-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-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-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-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-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-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