Food, drugs, devices › Codman & Shurtleff, Inc.

Device recall: NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovascul

FDA enforcement event 64158 · Class II · initiated 11 Jan 2013 · status Terminated · terminated 10 Aug 2015

DeviceVoluntary: Firm initiated24 product recordsRaynham, MA

FDA enforcement event 64158 is a device recall by Codman & Shurtleff, Inc. of Raynham, MA, initiated 11 Jan 2013 and classified Class II, with 24 product records.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 10 Aug 2015. Initiation: voluntary: firm initiated. Codman & Shurtleff, Inc. has 11 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Codman & Shurtleff, Inc., Raynham, MA.

Reason for recall

"Sterility of device may be compromised due to lack of package integrity"

Distribution

"Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania,…"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0842-2013	NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	867 units	Class II	Terminated	27 Feb 2013
Z-0843-2013	NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	19 units	Class II	Terminated	27 Feb 2013
Z-0844-2013	NEUROPATH 6Fx90 GUIDING CATH HH Product Code: GHH60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	56 units	Class II	Terminated	27 Feb 2013
Z-0845-2013	NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GHH51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	50 units	Class II	Terminated	27 Feb 2013
Z-0846-2013	NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	234 units	Class II	Terminated	27 Feb 2013
Z-0847-2013	NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	867 units	Class II	Terminated	27 Feb 2013
Z-0848-2013	NEUROPATH 5Fx100 GUIDING CATH MP Product Code:GMD51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	273 units	Class II	Terminated	27 Feb 2013
Z-0849-2013	NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	266 units	Class II	Terminated	27 Feb 2013
Z-0850-2013	NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	32 units	Class II	Terminated	27 Feb 2013
Z-0851-2013	NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	34 units	Class II	Terminated	27 Feb 2013
Z-0852-2013	NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	129 units	Class II	Terminated	27 Feb 2013
Z-0853-2013	NEUROPATH 5Fx100 GUIDING CATH MC Product Code: GCB51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	5 units	Class II	Terminated	27 Feb 2013
Z-0854-2013	NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	5 units	Class II	Terminated	27 Feb 2013
Z-0855-2013	NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	202 units	Class II	Terminated	27 Feb 2013
Z-0856-2013	NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	1548 units	Class II	Terminated	27 Feb 2013
Z-0857-2013	NEUROPATH 5Fx90 GUIDING CATH MPD Product Code: GMD50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	202 units	Class II	Terminated	27 Feb 2013
Z-0858-2013	NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	46 units	Class II	Terminated	27 Feb 2013
Z-0859-2013	NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	46 units	Class II	Terminated	27 Feb 2013
Z-0860-2013	NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	268 units	Class II	Terminated	27 Feb 2013
Z-0861-2013	NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	141 units	Class II	Terminated	27 Feb 2013
Z-0862-2013	NEUROPATH 6Fx90 GUIDING CATH MCV Product Code: GCB60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	10 units	Class II	Terminated	27 Feb 2013
Z-0863-2013	NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	64 units	Class II	Terminated	27 Feb 2013
Z-0864-2013	NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	25	Class II	Terminated	27 Feb 2013
Z-0865-2013	NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMC61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices	522 units	Class II	Terminated	27 Feb 2013

Context

90%of 2013 device events are Class II1,236 events that year

24product records in this eventfirm median: 2

11events on this register for the firm

Other enforcement events for Codman & Shurtleff, Inc.

Initiated	Product (first record)	Type	Class	Records
16 May 2019	GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).	Device	Class II	1
10 Nov 2015	MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the i	Device	Class II	2
5 Mar 2015	CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable	Device	Class II	1
15 Sep 2014	Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for	Device	Class II	3
3 Jul 2014	Codman Certas - In Line Valve Only; Product Code: 82-8800 The Codman Certas Programmable valve is an implantable device	Device	Class II	8
13 Dec 2013	CODMAN CERTAS Programmable Valves, central nervous system shunt, models as follows: 82-8800 In Line Valve Only 82-8801 I	Device	Class II	1
11 Oct 2013	TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil a	Device	Class I	2
13 Aug 2013	MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrath	Device	Class I	8
7 Jun 2013	MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4	Device	Class I	2
16 May 2013	Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable	Device	Class II	7

All 11 events for Codman & Shurtleff, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Sterility of device may be compromised due to lack of package integrity"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - USA (nationwide) and Internationally to Austria, Belgium, Canada, Chile, Costa, Rica, Czech Republic, Denmark, France, Germany, Great Britian/UK, Ireland, Italy, Lithuania,…"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 10 Aug 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.