Boston Scientific device recall labeled Class I | FTC to block $8.5B Capri takeover | Kraft Heinz sued over Lunchables contamination

In today’s Portfolio Intelligence Daily, where we highlight non-financial risks lurking under the radar with private companies and equities worldwide:?

• Boston Scientific device recall labeled Class I
• FTC to block $8.5B Capri takeover
• Kraft Heinz sued over Lunchables contamination

Our analyst team curates these summaries from Auquan’s Intelligence Engine, which uses generative AI and retrieval augmented generation (RAG) to uncover material non-financial insights at scale, such as emerging reputational risks of private companies and global supply chains.

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Boston Scientific device recall labeled Class I

Boston Scientific's Obsidio Embolic device recall is classified by the FDA as "most serious" due to heightened risk of bowel ischemia during GI bleeding procedures; Boston advises against a specific technique.

• The recall was prompted by a higher risk of bowel ischemia when the device was used with a specific technique during gastrointestinal (GI) bleeding procedures.
• Bowel ischemia involves reduced blood flow to the intestines, resulting in severe abdominal pain.
• The FDA reported 11 incidents, seven injuries, and two deaths related to this issue.
• The recall is categorized as a correction, not a product removal.
• Boston Scientific advised against using the aliquot technique with Obsidio Embolic for procedures treating lower GI bleeding.

Select timeline

• April 18, 2024 | FDA classifies recall of Boston Scientific device as 'most serious' (ET HealthWorld)
• April 17, 2024 | FDA classifies recall of Boston Scientific device to treat hemorrhaging as 'most serious' (SaltWire)
• April 17, 2024 | Boston Scientific has a serious recall involving embolization tech (MassDevice)

FTC to block $8.5B Capri takeover

Tapestry's $8.5 billion acquisition of Capri, owner of Michael Kors, faces FTC opposition despite EU and Japan approvals.

• The U.S. Federal Trade Commission (FTC) is preparing to sue to block Tapestry's $8.5 billion deal to buy Capri, the parent company of Michael Kors, according to a report from NYT Dealbook.
• The deal, which would unite luxury brands like Kate Spade, Stuart Weitzman, Jimmy Choo, and Versace, received regulatory clearance from the EU and Japan but faces scrutiny from the FTC.
• The FTC's commissioners are expected to meet to discuss the case, potentially leading to a formal vote on whether to file a lawsuit.
• The merger aimed to create a U.S. fashion powerhouse to compete with European rivals amid a luxury spending slowdown.

Select timeline

• April 17, 2024 | US FTC preparing to sue to block $8.5 bln takeover of Capri by Tapestry, NYT Dealbook reports (Reuters)
• April 15, 2024 | Tapestry merger with Versace owner Capri gets EU, Japan approval (Reuters)
• August 10, 2023 | Coach owner Tapestry to acquire Michael Kors, Jimmy Choo parent Capri Holdings for $8.5 billion (CNBC)

Kraft Heinz sued over lead and cadmium contamination in Lunchables products

Consumer Reports, an advocacy group, petitions USDA to remove Kraft Heinz's Lunchables from the National School Lunch Program due to high lead, cadmium, and sodium levels, along with Phthalates.

• The petition, with over 16,000 signatures, argues that Lunchables aren't a healthy choice for kids and shouldn't be part of the NSLP menu.
• Kraft Heinz developed school-specific Lunchables with more protein, whole grains, and reduced sodium to meet NSLP standards, but Consumer Reports tests show troubling results.
• Tests reveal higher sodium levels in school-only Lunchables compared to retail versions, exceeding recommended daily intake for children.
• Additionally, all tested Lunchables contain lead or cadmium, with some exceeding California's maximum allowable dose level, posing health risks, especially to children.
• Phthalates, known endocrine disruptors, were found in all but one of the tested snack kits, along with additives like sodium nitrite and artificial flavors, raising concerns about health impacts.

Select timeline

• April 17, 2024 | Kraft Sued Over Lead Contamination In Lunchables (Law360)
• April 15, 2024 | Kraft Heinz Sued Over Lunchables, Parents Claim High Levels Of Metal (TMZ)
• April 11, 2024 | Kraft Heinz's Lunchables Contain 'Relatively High' Levels of Lead, Cadmium, and Sodium, Tests Show (Food & Wine)

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