# K030187: Reprocessed Electrophysiology Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical, Inc.
- Decided: Sep 24, 2003 after 246 days
- Product code: NLH (Catheter, Recording, Electrode, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.1220
- Recalls of this device: 28 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K874208 (1987). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891908: Bard (R) Tip Deflecting Electrode Catheter, C.R. Bard, Inc. (1989) Summary page 5.
- K874208: Bard Octapolar Electrode Catheter, C.R. Bard, Inc. (1987) Summary page 5.
- K881966: Electrophysiology Electrode Cath. W/Silver/Silver, C.R. Bard, Inc. (1988) Summary page 5.
- K992373: Orbiter ST Diagnostic Electrode Catheter & Orbiter ST Extension Cable, C.R. Bard, Inc. (1999) Summary page 5.

## Recalls of this device
- Aug 18, 2026 · Class II · Z-0085-2027: Diagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could lead to particulate embolization, infection, thrombus
- Apr 10, 2026 · Class II · Z-2192-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2196-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2189-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2191-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2185-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2182-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2198-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2195-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2193-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2194-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2183-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2197-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2177-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2186-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2187-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2176-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2175-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2178-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2179-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2181-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2199-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2184-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2180-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2174-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2190-2026: Incomplete seals on sterile product
- Apr 10, 2026 · Class II · Z-2188-2026: Incomplete seals on sterile product
- Oct 18, 2013 · Class II · Z-0340-2014: Stryker Sustainability Solutions is recalling the Reprocessed Diagnostic Electrophysiology (EP) Catheters Cables due to a potential sterility breach in the package seal.

## Indications for use
Reprocessed Electrophysiology (EP) Catheters are indicated for temporary intracardiac sensing, recording, stimulation and electrophysiological mapping of cardiac structures. Reprocessed Electrophysiology Catheter Cables are indicated for use with the appropriate electrode catheter during electrophysiology studies.

Source page: https://510kreport.com/device/K030187
Methodology: https://510kreport.com/methodology