# FDA recall Z-1117-2021

> **Medtronic Neurosurgery** · Class II · device recall initiated 2021-01-11.

## Product

Medtronic PS Medical  Cerebro Spinal Fluid (CSF)-Flow Control Valves  for the following CFNs:    22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW  22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L  22011 M - SHUNT 22011 M INTL ONLY ULTRA SM MED  22017 B-L - SHUNT 22017 B-L ASSY US PER 90CM SM LOW  22017 B-M - SHUNT 22017 B-M ASSY US PER 90CM SM MED  22017B-LL - SHUNT 22017B-LL ASSY US PER 90CM SM LL  23093 - VALVE 23093 CONT. REG. LOW-LOW  27102 - VALVE 27102 CONTOURED SML LOW LOW  27553 M - VALVE 27553 M CSF-FLOW CNTRL SM EXTR MP  27643M - SHUNT 27643M ASSY SM PCATH130CM MED  27683M - SHUNT 27683M RG SNP PCATH90 PLI STD OE  42312 - VALVE 42312 SM CONTOURED LOW PRES IMP  42314- VALVE 42314 SM CONTOURED MED PRESS IMP  42316 - VALVE 42316 SM CONTOURED HIGH PRESS  42322 - VALVE 42322 CONTOURED REG LOW PRESS IMP  42324 - VALVE 42324 CONTOURED REG MED PRESS IMP  42326 - VALVE 42326 CONT HIGH PRESS IMP  42410 - VALVE 42410 ULTRA SMALL LOW-LOW  42414 - VALVE 42414 ULTRA SMALL MEDIUM PRESS IMP  42

## Reason for recall

Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

## Distribution

Worldwide distribution.  US nationwide,  Albania,  Algeria,  Argentina,  Armenia,  Australia,  Austria,  Bahrain,  Bangladesh,  Belgium,  Plurinational State Of Bolivia,   Bosnia And Herzegovina,  Botswana,  Brazil,  Brunei Darussalam,  Bulgaria,  Canada,  Canary Islands,  Cayman Islands,  Chile,  China,  Colombia,  Costa Rica,  Croatia,  Curacao,  Cyprus,  Czech Republic,  Denmark,  Dominican Republic,  Ecuador,  Egypt,  El Salvador,  Finland,  France,  Gabon,  Georgia,  Germany,  Ghana,  Greece,  Guatemala,  Honduras,  Hong Kong,  Hungary,  Iceland,  Indonesia,   Islamic Republic Of Iran,  Iraq,  Ireland,  Israel,  Italy,  Jamaica,  Japan,  Jordan,  Kazakhstan,   Republic Of Korea,  Kuwait,  Lao People's Democratic Republic,  Latvia,  Lebanon,  Libyan Arab Jamahiriya,  Lithuania,  Macao,  Malaysia,  Malta,  Mauritania,  Mexico,  Montenegro,  Netherlands,  New Zealand,  Nicaragua,  Nigeria,  North Macedonia,  Norway,  Oman,  Pakistan,  Panama,  Papua New Guinea,  Paraguay,  Peru,  Phi

## Key facts

- **Recall number:** Z-1117-2021
- **Recalling firm:** Medtronic Neurosurgery
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-01-11
- **Report date:** 2021-02-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1117-2021

## Citation

> AI Analytics. FDA recall Z-1117-2021. Retrieved 2026-08-19 from https://api.ai-analytics.org/recall/Z-1117-2021. Source: US FDA. Licensed CC0.

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